Amanda Rao - Profile on Academia.edu (original) (raw)
Papers by Amanda Rao
Skin pharmacology and physiology, Feb 26, 2024
Introduction: Eczema is a debilitating skin disorder clinically characterised by the development ... more Introduction: Eczema is a debilitating skin disorder clinically characterised by the development of itchy, dry, rough, and scaling skin caused by a series of rudimentary clinical phenotypes. Methods: This double-blind, randomised, comparatorcontrolled trial evaluated the effectiveness of topical application of a novel palmitoylethanolamide formulation (Levagen+) compared with a standard moisturiser (comparator) to reduce eczema severity and improve patient outcomes. Seventy-two participants aged over 18 years old with atopic eczema (symptoms including redness, dry skin, scaling, and/or itchiness) on their hands or arm were recruited. Participants were randomly allocated to one of two treatment groups (Levagen + or comparator). Treatment was applied to the affected area twice daily for 4 weeks. Outcome measures included Self-Assessed Eczema Area Severity Index (SA-EASI) scoring and Patient-Oriented Eczema Measure (POEM) from baseline to week 4. Results: Levagen+ was effective at alleviating symptom severity of eczema over 4 weeks. Levagen+ significantly reduced redness, dryness, and total POEM score compared to a comparator cream. Conclusion: Levagen+ can significantly reduce eczema symptom severity compared to a comparator product, supporting its use as a potential treatment for eczema. Trial registration: clinicaltrials.gov Identifier: NCT05003453.
Phytotherapy Research, Apr 24, 2015
The aim of the study was to evaluate the effect of Trigonella foenum-graecum (fenugreek) seed ext... more The aim of the study was to evaluate the effect of Trigonella foenum-graecum (fenugreek) seed extract on sex hormones and sexual function in healthy menstruating women who reported low sexual drive. This short term, single site, double blind, randomised, placebo-controlled study was conducted on 80 women, aged 20 to 49 years. Participants were randomised to either an oral dose of a standardised T. foenum-graecum seed extract (libifem) at a dose of 600 mg/day or placebo over two menstrual cycles. Dehydroepiandrosterone sulfate, progesterone, androstenedione, total and free testosterone, estradiol (E2), luteinizing hormone, follicle stimulating hormone, sex hormone binding globulin and cholesterol were measured at baseline and 8 weeks. The individual aspects of sexual function were measured using the Derogatis interview for sexual functioning and female sexual function index self-administered questionnaires. Stress, fatigue and quality of the relationship with partner were also measured using the PSS (Perceived Stress Scale), MFI-20 (Multidimensional Fatigue Inventory) and DAS (Dyadic Adjustment Scale) quality of life measures, respectively. There was a significant increase in free testosterone and E2 in the active group as well as sexual desire and arousal compared with the placebo group. The results indicate that this extract of T. foenum-graecum may be a useful treatment for increasing sexual arousal and desire in women.
Frontiers in sports and active living, Aug 11, 2023
Introduction: This study examined the effects of Libifem ® on exercise performance and body compo... more Introduction: This study examined the effects of Libifem ® on exercise performance and body composition in females 25-45 years old. Methods: Participants were randomized to three equal groups to consume: 600 mg Libifem ® /day, 300 mg Libifem ® /day or a placebo for 8 weeks. Participants completed a whole-body exercise program three times a week for 8 weeks. At baseline, week 4 and week 8, muscle strength and endurance, functional threshold power, body composition, and sex hormones were measured. At week 8, all three groups increased leg press 1RM compared to baseline. Results: A significant difference between group treatment effect was seen for leg press at week 8 (p = 0.045), with the 600 mg Libifem ® group significantly increasing their leg press 1RM compared to placebo (p = 0.014). The 600 mg Libifem ® group significantly reduced their total fat mass (0.96 kg loss) from baseline compared to placebo group (0.09 kg gain). There was no significant difference in fat mass for the 300 mg Libifem ® group (0.23 kg loss). The 600 mg Libifem ® group had a significant increase in lean mass compared to both the 300 mg and placebo groups (p = 0.011 and 0.009, respectively). Discussion: Overall, there were significant and dose-related changes in body composition and ergogenic parameters, comparable with previous findings in males. Trial Registration: This trial was registered with the Australian and New Zealand Clinical Trials registry [ACTRN12618001538235].
Food and Nutrition Sciences, 2022
Background: Palmitoylethanolamide (PEA) has shown promise as an analgesic for those with chronic ... more Background: Palmitoylethanolamide (PEA) has shown promise as an analgesic for those with chronic pain pathologies. With recently increased bioavailability, PEA may also be a treatment for acute pain presentations such as tension-type headaches. Aim: To assess the efficacy of a bioavailable PEA formulation (Levagen+ TM) for reducing the severity and duration of acute episodes of tension-type headaches when compared to a standard treatment, nonsteroidal anti-inflammatory drug (NSAID) (the comparator). Methods: The study was a double-blind, randomized, single site, comparator controlled clinical study, with the cohort consisting of otherwise healthy adults, aged between 18 and 71, who experienced regular tension-type headaches. 94 adults experiencing headaches were randomised to receive either PEA (n = 47) or Ibuprofen comparator (n = 47). Upon headache onset, participants consumed their allocated product, recorded pain levels using a visual analogue scale (VAS) and continued to log their pain scores at 30-minute intervals for up to 4-hours. Results: Eighty-six participants (44 active treatment and 42 comparator) recorded at least one headache with a total of 271 tension-type headaches recorded (120 active treatment and 151 comparator). Most headaches were reduced in both treatment arms by 2 hours and almost all by 4 hours;
European journal of nutrition, Jul 4, 2018
Purpose Curcumin has been shown to deliver protective effects against numerous degenerative condi... more Purpose Curcumin has been shown to deliver protective effects against numerous degenerative conditions associated with high levels of inflammation and oxidative stress. Owing to its poor bioavailability when delivered orally, it is difficult to deliver a high concentration therapeutic dose. LipiSperse ® is a novel delivery system that uses dispersion technology to enhance bioavailability of hydrophobic agents. In this study, we investigated the pharmacokinetics of a commercially available curcumin extract, with or without the curcumin-LipiSperse ® delivery complex. Methods Eighteen healthy male and female volunteers participated in this single equivalent dose, randomised, doubleblinded study. Seven of those volunteers further participated in the crossover phase of the trial. Plasma concentrations were determined at baseline and at regular intervals over a 24-h period following 750 mg of curcuminoid ingestion. In both the parallel and crossover trial, Curcumin with LipiSperse ® delivered significantly higher plasma curcuminoid concentrations compared to the raw curcumin product (807 vs 318 ng/mL in the crossover trial). Conclusions The novel delivery system LipiSperse ® is safe in humans, and demonstrates superior bioavailability for the supply of curcumin when compared to a standard curcumin extract.
Efficacy of an Oral Ageratum Conyzoides Formulation on Increasing Hair Growth and Decreasing Hair Loss in Males and Females: A Randomised Double-Blind Placebo-Controlled Study
Trichology and Cosmetology – Open Journal
Background Androgenetic alopecia (AGA) is associated with the enzyme 5a-reductase and prostagland... more Background Androgenetic alopecia (AGA) is associated with the enzyme 5a-reductase and prostaglandin D2, both of which are increased in bald areas of the scalp. We previously demonstrated the safety and efficacy of a topical Ageratum conyzoides (A. conyzoides) formulation in improving hair growth and decreasing hair loss. Objective A follow-up 12-week double-blind, randomised clinical trial investigating the efficacy and safety of A. conyzoides extract in an oral formulation, in males and females over 18-years of age. Methods 250 mg of A. conyzoides or a placebo was supplemented daily over a 12-week period to 84 healthy males or females with hair loss. The primary outcome was hair growth assessed by measuring hair density using HairCheck®, and hairline recession. Hair loss was measured by the mean number of hairs lost in a one-minute combing test and hair/tug pull test. Other assessments included Norwood/Hamilton and Ludwig-Savin scales evaluating male and female pattern baldness, re...
Food and Nutrition Sciences, 2023
Background: Irritable bowel syndrome affects one in five Australians, with abdominal pain as one ... more Background: Irritable bowel syndrome affects one in five Australians, with abdominal pain as one of the main symptoms. Lactoferrin, found in milk, is known for its anti-inflammatory properties, and the development of a novel microencapsulated form, Inferrin TM , may be useful in the treatment of irritable bowel syndrome symptoms. The current study aimed to study the effectiveness of Inferrin TM compared to lactoferrin and a placebo on irritable bowel syndrome symptoms. Methods: Sixty-eight male and female participants over 18 years of age were recruited to complete 8 weeks of supplementation with either Inferrin TM , lactoferrin, or a matched placebo. Outcomes were measured at baseline, week 4, and week 8. Results: There was a decrease from baseline across all groups in IBS symptom severity at weeks 4 and 8, as well as improvements in QOL scores. Lactoferrin and Inferrin TM groups had a significant reduction from baseline to week 8 in weekly stool frequency. Conclusions: Overall, lactoferrin and Inferrin TM appeared to have an effect in decreasing symptoms of IBS and weekly stool frequency.
Pharmaceutics, Nov 14, 2022
Background: This was an exploratory study to assess the safety and efficacy of a specialized Trig... more Background: This was an exploratory study to assess the safety and efficacy of a specialized Trigonella foenum-graceum L. seed extract for supporting healthy blood glucose metabolism in a pre-diabetic cohort. Methods: Fifty-four participants were randomised to receive 500 mg/day of T. foenum-graecum seed extract or matching placebo daily for 12 weeks. Fasting blood glucose (FBG), post-prandial glucose (PPBG), HbA1c, fasting insulin (FI), post-prandial insulin (PPI) and C-peptide were assessed at baseline, week 6 and week 12. Lipid levels, liver enzymes and C-reactive protein (CRP), along with safety markers and tolerability were also assessed at baseline and week 12. Results: By week 12 there was a significant difference in FBG (p < 0.001), PPBG (p = 0.007) and triglycerides (p = 0.030) between treatment groups, with no changes in HbA1c (p = 0.41), FI (p = 0.12), PPI (p = 0.50) or C-peptide (p = 0.80). There was no difference in total cholesterol (p = 0.99), high-density lipoprotein (p = 0.35), low density lipoprotein (p = 0.60) or CRP (p = 0.79). There was no change in safety markers and the treatment was well tolerated. Conclusions: The results of the study indicated that T. foenumgraecum seed extract may influence blood glucose metabolism and larger studies are warranted to evaluate efficacy and potential mechanisms of action.
Inflammopharmacology
Background Peripheral neuropathy is a common complication of diabetes. The management of the asso... more Background Peripheral neuropathy is a common complication of diabetes. The management of the associated neuropathic pain remains difficult to treat. Objective This study explored the safety, tolerability and efficacy of a palmitoylethanolamide (PEA) formulation in treating diabetic-related peripheral neuropathic pain (PNP). Secondary outcomes included systemic inflammation, sleep and mood changes in patients diagnosed with type 1 and type 2 diabetes and PNP. Design This study was a single-centre, quadruple-blinded, placebo-controlled trial with 70 participants receiving 600 mg of PEA or placebo daily, for 8 weeks, with a 94% rate of study participation completion. Primary outcomes were neuropathic pain and specific pain types (the BPI-DPN and NPSI). The secondary outcomes were sleep quality (MOS sleep scale), mood (DASS-21), glucose metabolism and inflammation. Results There was a significant reduction (P ≤ 0.001) in BPI-DPN total pain and pain interference, NPSI total score and sub...
Nutrients
Introduction: Upper respiratory tract infections (URTIs) are caused by bacteria or viruses, with ... more Introduction: Upper respiratory tract infections (URTIs) are caused by bacteria or viruses, with the most common causes being the common cold and influenza. The high occurrence of URTI means therapies that are effective with minimal side effects are in constant demand. Palmitoylethanolamide (PEA) is a signaling lipid previously shown to be effective in improving the incidence of URTIs. The aim of this study was to assess the effectiveness of PEA (Levagen+) on URTI incidence, duration, and severity. Methods: Participants (n = 426) consumed either 300 mg of Levagen+ or a placebo (maltodextrin) twice daily for 12 weeks. Participants completed the Wisconsin Upper Respiratory Symptom Survey 24 questionnaire daily upon the commencement of symptoms until symptoms subsided. Results: The Levagen+ group reported fewer URTI episodes (39 vs. 64) compared to the placebo group. The Levagen+ group reported a significant reduction in the median severity score of URTI symptoms for scratchy throat (3...
Nutrients
This study aimed to assess the efficacy of a blood orange Citrus sinensis standardized extract fr... more This study aimed to assess the efficacy of a blood orange Citrus sinensis standardized extract from “Moro” cultivar, on weight loss in overweight but otherwise healthy individuals. Anthocyanins and particularly cyanidin 3-glucoside, found in a large variety of fruits including Sicilian blood oranges, can help to counteract weight gain and to reduce body fat accumulation through the modulation of antioxidant, anti-inflammatory and metabolic pathways. In this randomized, double blind, placebo-controlled study, all participants (overweight adults aged 20–65 years old) were randomized to receive either Moro blood orange standardized extract or a placebo daily for 6-months. The primary outcome measure was change in body mass and body composition at the end of the study. After 6-months, body mass (4.2% vs. 2.2%, p = 0.015), body mass index (p = 0.019), hip (3.4 cm vs. 2.0 cm, p = 0.049) and waist (3.9 cm vs. 1.7 cm, p = 0.017) circumferences, fat mass (p = 0.012) and fat distribution (vis...
BMC Complementary Medicine and Therapies
Background Ginkgo biloba extracts (GBE) have been used in traditional medicines for centuries. GB... more Background Ginkgo biloba extracts (GBE) have been used in traditional medicines for centuries. GBE has been shown to deliver protective effects against symptoms of age-related cognitive decline. Despite there being standardised extractions for GBE, there is still variability in the absorption and efficacy of different extracts. Following the development of a liposomal GBE (Ginkgosome™), the aim of this study is to investigate the absorption of the liposomal formulation compared to a comparator formulation of equal dose. Methods Thirteen healthy male and female volunteers completed this single equivalent dose, randomised, double-blind crossover study. Plasma concentrations were determined at baseline and at regular intervals over a 24-h period following ingestion of 120 mg of either a liposomal or comparator formulation. Results The liposomal formulation was able to increase plasma concentration of ginkgolide B and C by 1.9 and 2.2-fold compared to the comparator formulation. Conclus...
International Journal of Nutrition and Food Sciences, 2021
A commonality of all joint pain is the existence of inflammation. Palmitoylethanolamide (PEA) is ... more A commonality of all joint pain is the existence of inflammation. Palmitoylethanolamide (PEA) is an endogenous saturated fatty acid derivative that down-regulates multiple proinflammatory and nociceptive pathways and known to inhibit mast and glial cell activity. This study aimed to assess the efficacy of PEA (Levagen+), for alleviating joint pain and improving quality of life in adults. A randomised, double blind, placebo-controlled study on adults reporting joint pain. 74 participants that received either PEA (n=35) or a placebo (n=39) daily for 2 weeks completed this study. The primary outcome was a selfassessed reduction in pain as assessed by a visual analogue scale (VAS) for pain, completed in the morning and evening. VAS pain scores reduced over the 2 weeks of treatment in both groups. Morning VAS scores were significantly reduced from baseline in the PEA and placebo groups from day 3 and 4 respectively. VAS scores were significantly lower in the PEA group compared to the placebo group on day 14 (P<0.05). Evening VAS scores were significantly reduced from baseline in both the PEA and placebo groups from day 3. Total mood scores for both groups were similar at baseline but was significantly different at the end of the study, with the PEA group decreasing and the placebo group increasing. This study demonstrates that PEA may be a safe and effective option for reducing joint pain. Future studies should investigate whether long-term supplementation can show further improvements in pain scores.
Scientific Reports, 2021
To examine the effect of a Caralluma Fimbriata extract (CFE) on biomarkers of satiety and body co... more To examine the effect of a Caralluma Fimbriata extract (CFE) on biomarkers of satiety and body composition in overweight adults. A double-blind, randomised, placebo controlled trial to examine the effect of a Caralluma Fimbriata extract (CFE) on biomarkers of satiety and body composition in overweight adults. Eighty-three men and women aged between 20 and 50 years of age completed 16 weeks of daily supplementation with either CFE or placebo. Plasma cardiometabolic (lipid profile, glucose, insulin) and satiety (ghrelin, leptin, neuropeptideY) biomarkers, body composition, diet history and gastrointenstinal function were assessed at baseline, weeks 4, 8, 12 and 16. Subjects in the CFE and placebo groups were well matched and predominatly female 93% and 87.5%, with a mean age of 40.9 ± 6.7 and 39.5 ± 7.5 years and body mass index (BMI) of 30.0 ± 3.1 and 30.2 ± 2.9 kg/m2 respectively. There was a significant difference in plasma leptin concentration change between groups at week 16 (p =...
Use of a new saffron extract for the prevention of mood disorder associated with depression
Use of a new saffron extract for the prevention of mood disorders related to depression. # The pr... more Use of a new saffron extract for the prevention of mood disorders related to depression. # The present invention relates to a powder composition obtained from a saffron stigma extract characterized in that it comprises between 0.03% and 1% dry weight of safranal; and at least 3.48% by dry weight of major crocins that encompasses the different isomers of trans-crocin-4 (main isomer), trans-crocin-3, trans-crocin-2 ', cis-crocin-4, trans- crocin-2, trans-crocin-1 and any of its mixtures.
Title: A Pharmacokinetic study showing the increased absorption of palmitoylethanolamide using Li... more Title: A Pharmacokinetic study showing the increased absorption of palmitoylethanolamide using LipiSperse®. Background: Palmitoylethanolamide (PEA) is a naturally occurring endogenous fatty acid that benefits human health by exerting a variety of biological functions related to chronic pain and inflammation. The aim of this trial was to determine whether the use of a novel crystalline dispersion technology, LipiSperse®, can be successfully used to improve the absorption of PEA. Method: A parallel, double-blind, absorption study to measure uptake of PEA over a 4-hour period. The study was conducted with 28 healthy male and female volunteers over 18 years old. Participants were randomised into 2 groups. One group consumed a single 300 mg dose of PEA together with the LipiSperse® delivery technology (commercially referred to as Levagen Plus), while the other group consumed a single 300 mg dose of unprocessed PEA. Blood samples were taken at baseline and 30, 45, 60, 70, 90, 120, 180, 24...
The effect of an orally‐dosed Gynostemma pentaphyllum extract (ActivAMP®) on body composition in overweight, adult men and women: A double‐blind, randomised, placebo‐controlled study
Journal of Human Nutrition and Dietetics, 2021
BackgroundThe present study examined the effect of a herbal supplement containing a Gynostemma pe... more BackgroundThe present study examined the effect of a herbal supplement containing a Gynostemma pentaphyllum (Gpp) extract (ActivAMP®) with respect to improving body composition in overweight males and females.MethodsOne‐hundred and seventeen men and women aged over 18 years completed 16 weeks of daily supplementation with either Gpp or a placebo. Participants underwent dual‐energy X‐rays to assess body composition (fat mass, lean mass and mass distribution), as well as anthropometric measures (weight, height, hip and waist circumference), in addition to blood tests to assess inflammatory and safety markers.ResultsFollowing 16 weeks of treatment, the Gpp group had a significant reduction in total body weight, body mass index, total fat mass and gynoid fat mass compared to the placebo group. Blood measures showed plasma triglyceride, alanine aminotransferase and tumour necrosis factor‐α to be statistically different between groups at week 16. Subgroup analysis of gender for fat distri...
Background: Sleep is essential for wellbeing, yet sleep disturbance is a common problem linked to... more Background: Sleep is essential for wellbeing, yet sleep disturbance is a common problem linked to a wide range of health conditions. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide proposed to promote better sleep via potential interaction with the endocannabinoid system.Methods: This double-blind, randomized study on 103 adults compared the efficacy and tolerability of 8 weeks of daily supplemented PEA formulation (350 mg Levagen+TM) to a placebo. Sleep quality and quantity were measured using wrist actigraphy, a sleep diary and questionnaires. Results: At week 8, PEA supplementation reduced sleep onset latency, time to feel completely awake and improved cognition on waking. After 8 weeks, both groups improved their sleep quality and quantity scores similarly. There was no difference between groups at baseline or week 8 for sleep quantity or quality as measured from actigraphy or sleep diaries. Conclusion: These findings support PEA as a potential sleeping aid capable...
Pharmaceutics, 2020
Resveratrol is a naturally produced compound that has been well researched for its potential heal... more Resveratrol is a naturally produced compound that has been well researched for its potential health benefits. The primary hindrance towards resveratrol’s therapeutic efficacy is its traditionally poor oral bioavailability. LipiSperse® is a novel delivery system designed to increase the dispersion of lipophilic ingredients, like resveratrol, in aqueous environments. This single-dose, double-blind, randomized study compared the pharmacokinetics of a commercially available resveratrol with (Veri-Sperse®) and without (Veri-te) the LipiSperse® delivery complex. Healthy adults randomly received a single dose of either 150 Veri-te, 75 Veri-Sperse®, or 150 mg Veri-Sperse®. Venous blood samples were taken prior to dosing in a fasted state and at 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 h post supplementation. Plasma trans-resveratrol conjugates were measured by liquid-chromatography tandem mass spectrometry (LC-MS/MS). The area under the curve (AUC) (0–24 h), maximum concentration (Cmax), and time of...
Skin pharmacology and physiology, Feb 26, 2024
Introduction: Eczema is a debilitating skin disorder clinically characterised by the development ... more Introduction: Eczema is a debilitating skin disorder clinically characterised by the development of itchy, dry, rough, and scaling skin caused by a series of rudimentary clinical phenotypes. Methods: This double-blind, randomised, comparatorcontrolled trial evaluated the effectiveness of topical application of a novel palmitoylethanolamide formulation (Levagen+) compared with a standard moisturiser (comparator) to reduce eczema severity and improve patient outcomes. Seventy-two participants aged over 18 years old with atopic eczema (symptoms including redness, dry skin, scaling, and/or itchiness) on their hands or arm were recruited. Participants were randomly allocated to one of two treatment groups (Levagen + or comparator). Treatment was applied to the affected area twice daily for 4 weeks. Outcome measures included Self-Assessed Eczema Area Severity Index (SA-EASI) scoring and Patient-Oriented Eczema Measure (POEM) from baseline to week 4. Results: Levagen+ was effective at alleviating symptom severity of eczema over 4 weeks. Levagen+ significantly reduced redness, dryness, and total POEM score compared to a comparator cream. Conclusion: Levagen+ can significantly reduce eczema symptom severity compared to a comparator product, supporting its use as a potential treatment for eczema. Trial registration: clinicaltrials.gov Identifier: NCT05003453.
Phytotherapy Research, Apr 24, 2015
The aim of the study was to evaluate the effect of Trigonella foenum-graecum (fenugreek) seed ext... more The aim of the study was to evaluate the effect of Trigonella foenum-graecum (fenugreek) seed extract on sex hormones and sexual function in healthy menstruating women who reported low sexual drive. This short term, single site, double blind, randomised, placebo-controlled study was conducted on 80 women, aged 20 to 49 years. Participants were randomised to either an oral dose of a standardised T. foenum-graecum seed extract (libifem) at a dose of 600 mg/day or placebo over two menstrual cycles. Dehydroepiandrosterone sulfate, progesterone, androstenedione, total and free testosterone, estradiol (E2), luteinizing hormone, follicle stimulating hormone, sex hormone binding globulin and cholesterol were measured at baseline and 8 weeks. The individual aspects of sexual function were measured using the Derogatis interview for sexual functioning and female sexual function index self-administered questionnaires. Stress, fatigue and quality of the relationship with partner were also measured using the PSS (Perceived Stress Scale), MFI-20 (Multidimensional Fatigue Inventory) and DAS (Dyadic Adjustment Scale) quality of life measures, respectively. There was a significant increase in free testosterone and E2 in the active group as well as sexual desire and arousal compared with the placebo group. The results indicate that this extract of T. foenum-graecum may be a useful treatment for increasing sexual arousal and desire in women.
Frontiers in sports and active living, Aug 11, 2023
Introduction: This study examined the effects of Libifem ® on exercise performance and body compo... more Introduction: This study examined the effects of Libifem ® on exercise performance and body composition in females 25-45 years old. Methods: Participants were randomized to three equal groups to consume: 600 mg Libifem ® /day, 300 mg Libifem ® /day or a placebo for 8 weeks. Participants completed a whole-body exercise program three times a week for 8 weeks. At baseline, week 4 and week 8, muscle strength and endurance, functional threshold power, body composition, and sex hormones were measured. At week 8, all three groups increased leg press 1RM compared to baseline. Results: A significant difference between group treatment effect was seen for leg press at week 8 (p = 0.045), with the 600 mg Libifem ® group significantly increasing their leg press 1RM compared to placebo (p = 0.014). The 600 mg Libifem ® group significantly reduced their total fat mass (0.96 kg loss) from baseline compared to placebo group (0.09 kg gain). There was no significant difference in fat mass for the 300 mg Libifem ® group (0.23 kg loss). The 600 mg Libifem ® group had a significant increase in lean mass compared to both the 300 mg and placebo groups (p = 0.011 and 0.009, respectively). Discussion: Overall, there were significant and dose-related changes in body composition and ergogenic parameters, comparable with previous findings in males. Trial Registration: This trial was registered with the Australian and New Zealand Clinical Trials registry [ACTRN12618001538235].
Food and Nutrition Sciences, 2022
Background: Palmitoylethanolamide (PEA) has shown promise as an analgesic for those with chronic ... more Background: Palmitoylethanolamide (PEA) has shown promise as an analgesic for those with chronic pain pathologies. With recently increased bioavailability, PEA may also be a treatment for acute pain presentations such as tension-type headaches. Aim: To assess the efficacy of a bioavailable PEA formulation (Levagen+ TM) for reducing the severity and duration of acute episodes of tension-type headaches when compared to a standard treatment, nonsteroidal anti-inflammatory drug (NSAID) (the comparator). Methods: The study was a double-blind, randomized, single site, comparator controlled clinical study, with the cohort consisting of otherwise healthy adults, aged between 18 and 71, who experienced regular tension-type headaches. 94 adults experiencing headaches were randomised to receive either PEA (n = 47) or Ibuprofen comparator (n = 47). Upon headache onset, participants consumed their allocated product, recorded pain levels using a visual analogue scale (VAS) and continued to log their pain scores at 30-minute intervals for up to 4-hours. Results: Eighty-six participants (44 active treatment and 42 comparator) recorded at least one headache with a total of 271 tension-type headaches recorded (120 active treatment and 151 comparator). Most headaches were reduced in both treatment arms by 2 hours and almost all by 4 hours;
European journal of nutrition, Jul 4, 2018
Purpose Curcumin has been shown to deliver protective effects against numerous degenerative condi... more Purpose Curcumin has been shown to deliver protective effects against numerous degenerative conditions associated with high levels of inflammation and oxidative stress. Owing to its poor bioavailability when delivered orally, it is difficult to deliver a high concentration therapeutic dose. LipiSperse ® is a novel delivery system that uses dispersion technology to enhance bioavailability of hydrophobic agents. In this study, we investigated the pharmacokinetics of a commercially available curcumin extract, with or without the curcumin-LipiSperse ® delivery complex. Methods Eighteen healthy male and female volunteers participated in this single equivalent dose, randomised, doubleblinded study. Seven of those volunteers further participated in the crossover phase of the trial. Plasma concentrations were determined at baseline and at regular intervals over a 24-h period following 750 mg of curcuminoid ingestion. In both the parallel and crossover trial, Curcumin with LipiSperse ® delivered significantly higher plasma curcuminoid concentrations compared to the raw curcumin product (807 vs 318 ng/mL in the crossover trial). Conclusions The novel delivery system LipiSperse ® is safe in humans, and demonstrates superior bioavailability for the supply of curcumin when compared to a standard curcumin extract.
Efficacy of an Oral Ageratum Conyzoides Formulation on Increasing Hair Growth and Decreasing Hair Loss in Males and Females: A Randomised Double-Blind Placebo-Controlled Study
Trichology and Cosmetology – Open Journal
Background Androgenetic alopecia (AGA) is associated with the enzyme 5a-reductase and prostagland... more Background Androgenetic alopecia (AGA) is associated with the enzyme 5a-reductase and prostaglandin D2, both of which are increased in bald areas of the scalp. We previously demonstrated the safety and efficacy of a topical Ageratum conyzoides (A. conyzoides) formulation in improving hair growth and decreasing hair loss. Objective A follow-up 12-week double-blind, randomised clinical trial investigating the efficacy and safety of A. conyzoides extract in an oral formulation, in males and females over 18-years of age. Methods 250 mg of A. conyzoides or a placebo was supplemented daily over a 12-week period to 84 healthy males or females with hair loss. The primary outcome was hair growth assessed by measuring hair density using HairCheck®, and hairline recession. Hair loss was measured by the mean number of hairs lost in a one-minute combing test and hair/tug pull test. Other assessments included Norwood/Hamilton and Ludwig-Savin scales evaluating male and female pattern baldness, re...
Food and Nutrition Sciences, 2023
Background: Irritable bowel syndrome affects one in five Australians, with abdominal pain as one ... more Background: Irritable bowel syndrome affects one in five Australians, with abdominal pain as one of the main symptoms. Lactoferrin, found in milk, is known for its anti-inflammatory properties, and the development of a novel microencapsulated form, Inferrin TM , may be useful in the treatment of irritable bowel syndrome symptoms. The current study aimed to study the effectiveness of Inferrin TM compared to lactoferrin and a placebo on irritable bowel syndrome symptoms. Methods: Sixty-eight male and female participants over 18 years of age were recruited to complete 8 weeks of supplementation with either Inferrin TM , lactoferrin, or a matched placebo. Outcomes were measured at baseline, week 4, and week 8. Results: There was a decrease from baseline across all groups in IBS symptom severity at weeks 4 and 8, as well as improvements in QOL scores. Lactoferrin and Inferrin TM groups had a significant reduction from baseline to week 8 in weekly stool frequency. Conclusions: Overall, lactoferrin and Inferrin TM appeared to have an effect in decreasing symptoms of IBS and weekly stool frequency.
Pharmaceutics, Nov 14, 2022
Background: This was an exploratory study to assess the safety and efficacy of a specialized Trig... more Background: This was an exploratory study to assess the safety and efficacy of a specialized Trigonella foenum-graceum L. seed extract for supporting healthy blood glucose metabolism in a pre-diabetic cohort. Methods: Fifty-four participants were randomised to receive 500 mg/day of T. foenum-graecum seed extract or matching placebo daily for 12 weeks. Fasting blood glucose (FBG), post-prandial glucose (PPBG), HbA1c, fasting insulin (FI), post-prandial insulin (PPI) and C-peptide were assessed at baseline, week 6 and week 12. Lipid levels, liver enzymes and C-reactive protein (CRP), along with safety markers and tolerability were also assessed at baseline and week 12. Results: By week 12 there was a significant difference in FBG (p < 0.001), PPBG (p = 0.007) and triglycerides (p = 0.030) between treatment groups, with no changes in HbA1c (p = 0.41), FI (p = 0.12), PPI (p = 0.50) or C-peptide (p = 0.80). There was no difference in total cholesterol (p = 0.99), high-density lipoprotein (p = 0.35), low density lipoprotein (p = 0.60) or CRP (p = 0.79). There was no change in safety markers and the treatment was well tolerated. Conclusions: The results of the study indicated that T. foenumgraecum seed extract may influence blood glucose metabolism and larger studies are warranted to evaluate efficacy and potential mechanisms of action.
Inflammopharmacology
Background Peripheral neuropathy is a common complication of diabetes. The management of the asso... more Background Peripheral neuropathy is a common complication of diabetes. The management of the associated neuropathic pain remains difficult to treat. Objective This study explored the safety, tolerability and efficacy of a palmitoylethanolamide (PEA) formulation in treating diabetic-related peripheral neuropathic pain (PNP). Secondary outcomes included systemic inflammation, sleep and mood changes in patients diagnosed with type 1 and type 2 diabetes and PNP. Design This study was a single-centre, quadruple-blinded, placebo-controlled trial with 70 participants receiving 600 mg of PEA or placebo daily, for 8 weeks, with a 94% rate of study participation completion. Primary outcomes were neuropathic pain and specific pain types (the BPI-DPN and NPSI). The secondary outcomes were sleep quality (MOS sleep scale), mood (DASS-21), glucose metabolism and inflammation. Results There was a significant reduction (P ≤ 0.001) in BPI-DPN total pain and pain interference, NPSI total score and sub...
Nutrients
Introduction: Upper respiratory tract infections (URTIs) are caused by bacteria or viruses, with ... more Introduction: Upper respiratory tract infections (URTIs) are caused by bacteria or viruses, with the most common causes being the common cold and influenza. The high occurrence of URTI means therapies that are effective with minimal side effects are in constant demand. Palmitoylethanolamide (PEA) is a signaling lipid previously shown to be effective in improving the incidence of URTIs. The aim of this study was to assess the effectiveness of PEA (Levagen+) on URTI incidence, duration, and severity. Methods: Participants (n = 426) consumed either 300 mg of Levagen+ or a placebo (maltodextrin) twice daily for 12 weeks. Participants completed the Wisconsin Upper Respiratory Symptom Survey 24 questionnaire daily upon the commencement of symptoms until symptoms subsided. Results: The Levagen+ group reported fewer URTI episodes (39 vs. 64) compared to the placebo group. The Levagen+ group reported a significant reduction in the median severity score of URTI symptoms for scratchy throat (3...
Nutrients
This study aimed to assess the efficacy of a blood orange Citrus sinensis standardized extract fr... more This study aimed to assess the efficacy of a blood orange Citrus sinensis standardized extract from “Moro” cultivar, on weight loss in overweight but otherwise healthy individuals. Anthocyanins and particularly cyanidin 3-glucoside, found in a large variety of fruits including Sicilian blood oranges, can help to counteract weight gain and to reduce body fat accumulation through the modulation of antioxidant, anti-inflammatory and metabolic pathways. In this randomized, double blind, placebo-controlled study, all participants (overweight adults aged 20–65 years old) were randomized to receive either Moro blood orange standardized extract or a placebo daily for 6-months. The primary outcome measure was change in body mass and body composition at the end of the study. After 6-months, body mass (4.2% vs. 2.2%, p = 0.015), body mass index (p = 0.019), hip (3.4 cm vs. 2.0 cm, p = 0.049) and waist (3.9 cm vs. 1.7 cm, p = 0.017) circumferences, fat mass (p = 0.012) and fat distribution (vis...
BMC Complementary Medicine and Therapies
Background Ginkgo biloba extracts (GBE) have been used in traditional medicines for centuries. GB... more Background Ginkgo biloba extracts (GBE) have been used in traditional medicines for centuries. GBE has been shown to deliver protective effects against symptoms of age-related cognitive decline. Despite there being standardised extractions for GBE, there is still variability in the absorption and efficacy of different extracts. Following the development of a liposomal GBE (Ginkgosome™), the aim of this study is to investigate the absorption of the liposomal formulation compared to a comparator formulation of equal dose. Methods Thirteen healthy male and female volunteers completed this single equivalent dose, randomised, double-blind crossover study. Plasma concentrations were determined at baseline and at regular intervals over a 24-h period following ingestion of 120 mg of either a liposomal or comparator formulation. Results The liposomal formulation was able to increase plasma concentration of ginkgolide B and C by 1.9 and 2.2-fold compared to the comparator formulation. Conclus...
International Journal of Nutrition and Food Sciences, 2021
A commonality of all joint pain is the existence of inflammation. Palmitoylethanolamide (PEA) is ... more A commonality of all joint pain is the existence of inflammation. Palmitoylethanolamide (PEA) is an endogenous saturated fatty acid derivative that down-regulates multiple proinflammatory and nociceptive pathways and known to inhibit mast and glial cell activity. This study aimed to assess the efficacy of PEA (Levagen+), for alleviating joint pain and improving quality of life in adults. A randomised, double blind, placebo-controlled study on adults reporting joint pain. 74 participants that received either PEA (n=35) or a placebo (n=39) daily for 2 weeks completed this study. The primary outcome was a selfassessed reduction in pain as assessed by a visual analogue scale (VAS) for pain, completed in the morning and evening. VAS pain scores reduced over the 2 weeks of treatment in both groups. Morning VAS scores were significantly reduced from baseline in the PEA and placebo groups from day 3 and 4 respectively. VAS scores were significantly lower in the PEA group compared to the placebo group on day 14 (P<0.05). Evening VAS scores were significantly reduced from baseline in both the PEA and placebo groups from day 3. Total mood scores for both groups were similar at baseline but was significantly different at the end of the study, with the PEA group decreasing and the placebo group increasing. This study demonstrates that PEA may be a safe and effective option for reducing joint pain. Future studies should investigate whether long-term supplementation can show further improvements in pain scores.
Scientific Reports, 2021
To examine the effect of a Caralluma Fimbriata extract (CFE) on biomarkers of satiety and body co... more To examine the effect of a Caralluma Fimbriata extract (CFE) on biomarkers of satiety and body composition in overweight adults. A double-blind, randomised, placebo controlled trial to examine the effect of a Caralluma Fimbriata extract (CFE) on biomarkers of satiety and body composition in overweight adults. Eighty-three men and women aged between 20 and 50 years of age completed 16 weeks of daily supplementation with either CFE or placebo. Plasma cardiometabolic (lipid profile, glucose, insulin) and satiety (ghrelin, leptin, neuropeptideY) biomarkers, body composition, diet history and gastrointenstinal function were assessed at baseline, weeks 4, 8, 12 and 16. Subjects in the CFE and placebo groups were well matched and predominatly female 93% and 87.5%, with a mean age of 40.9 ± 6.7 and 39.5 ± 7.5 years and body mass index (BMI) of 30.0 ± 3.1 and 30.2 ± 2.9 kg/m2 respectively. There was a significant difference in plasma leptin concentration change between groups at week 16 (p =...
Use of a new saffron extract for the prevention of mood disorder associated with depression
Use of a new saffron extract for the prevention of mood disorders related to depression. # The pr... more Use of a new saffron extract for the prevention of mood disorders related to depression. # The present invention relates to a powder composition obtained from a saffron stigma extract characterized in that it comprises between 0.03% and 1% dry weight of safranal; and at least 3.48% by dry weight of major crocins that encompasses the different isomers of trans-crocin-4 (main isomer), trans-crocin-3, trans-crocin-2 ', cis-crocin-4, trans- crocin-2, trans-crocin-1 and any of its mixtures.
Title: A Pharmacokinetic study showing the increased absorption of palmitoylethanolamide using Li... more Title: A Pharmacokinetic study showing the increased absorption of palmitoylethanolamide using LipiSperse®. Background: Palmitoylethanolamide (PEA) is a naturally occurring endogenous fatty acid that benefits human health by exerting a variety of biological functions related to chronic pain and inflammation. The aim of this trial was to determine whether the use of a novel crystalline dispersion technology, LipiSperse®, can be successfully used to improve the absorption of PEA. Method: A parallel, double-blind, absorption study to measure uptake of PEA over a 4-hour period. The study was conducted with 28 healthy male and female volunteers over 18 years old. Participants were randomised into 2 groups. One group consumed a single 300 mg dose of PEA together with the LipiSperse® delivery technology (commercially referred to as Levagen Plus), while the other group consumed a single 300 mg dose of unprocessed PEA. Blood samples were taken at baseline and 30, 45, 60, 70, 90, 120, 180, 24...
The effect of an orally‐dosed Gynostemma pentaphyllum extract (ActivAMP®) on body composition in overweight, adult men and women: A double‐blind, randomised, placebo‐controlled study
Journal of Human Nutrition and Dietetics, 2021
BackgroundThe present study examined the effect of a herbal supplement containing a Gynostemma pe... more BackgroundThe present study examined the effect of a herbal supplement containing a Gynostemma pentaphyllum (Gpp) extract (ActivAMP®) with respect to improving body composition in overweight males and females.MethodsOne‐hundred and seventeen men and women aged over 18 years completed 16 weeks of daily supplementation with either Gpp or a placebo. Participants underwent dual‐energy X‐rays to assess body composition (fat mass, lean mass and mass distribution), as well as anthropometric measures (weight, height, hip and waist circumference), in addition to blood tests to assess inflammatory and safety markers.ResultsFollowing 16 weeks of treatment, the Gpp group had a significant reduction in total body weight, body mass index, total fat mass and gynoid fat mass compared to the placebo group. Blood measures showed plasma triglyceride, alanine aminotransferase and tumour necrosis factor‐α to be statistically different between groups at week 16. Subgroup analysis of gender for fat distri...
Background: Sleep is essential for wellbeing, yet sleep disturbance is a common problem linked to... more Background: Sleep is essential for wellbeing, yet sleep disturbance is a common problem linked to a wide range of health conditions. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide proposed to promote better sleep via potential interaction with the endocannabinoid system.Methods: This double-blind, randomized study on 103 adults compared the efficacy and tolerability of 8 weeks of daily supplemented PEA formulation (350 mg Levagen+TM) to a placebo. Sleep quality and quantity were measured using wrist actigraphy, a sleep diary and questionnaires. Results: At week 8, PEA supplementation reduced sleep onset latency, time to feel completely awake and improved cognition on waking. After 8 weeks, both groups improved their sleep quality and quantity scores similarly. There was no difference between groups at baseline or week 8 for sleep quantity or quality as measured from actigraphy or sleep diaries. Conclusion: These findings support PEA as a potential sleeping aid capable...
Pharmaceutics, 2020
Resveratrol is a naturally produced compound that has been well researched for its potential heal... more Resveratrol is a naturally produced compound that has been well researched for its potential health benefits. The primary hindrance towards resveratrol’s therapeutic efficacy is its traditionally poor oral bioavailability. LipiSperse® is a novel delivery system designed to increase the dispersion of lipophilic ingredients, like resveratrol, in aqueous environments. This single-dose, double-blind, randomized study compared the pharmacokinetics of a commercially available resveratrol with (Veri-Sperse®) and without (Veri-te) the LipiSperse® delivery complex. Healthy adults randomly received a single dose of either 150 Veri-te, 75 Veri-Sperse®, or 150 mg Veri-Sperse®. Venous blood samples were taken prior to dosing in a fasted state and at 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 h post supplementation. Plasma trans-resveratrol conjugates were measured by liquid-chromatography tandem mass spectrometry (LC-MS/MS). The area under the curve (AUC) (0–24 h), maximum concentration (Cmax), and time of...