Amanda Rao - Academia.edu (original) (raw)

Papers by Amanda Rao

Research paper thumbnail of Efficacy of topical palmitoylethanolamide (Levagen+) for the management of eczema symptoms: A double blind, comparator controlled, randomized clinical trial

Skin pharmacology and physiology, Feb 26, 2024

Research paper thumbnail of The Effect of Levagen+ (Palmitoylethanolamide) Supplementation on Symptoms of Allergic Rhinitis—A Double-Blind Placebo-Controlled Trial

Research paper thumbnail of Influence of a Specialized <i>Trigonella foenum-graecum</i> Seed Extract (Libifem), on Testosterone, Estradiol and Sexual Function in Healthy Menstruating Women, a Randomised Placebo Controlled Study

Phytotherapy Research, Apr 24, 2015

Research paper thumbnail of Libifem® (Trigonella foenum-graecum) in conjunction with exercise on muscle strength, power, endurance, and body composition in females aged between 25 and 45 years

Frontiers in sports and active living, Aug 11, 2023

Research paper thumbnail of Efficacy of Palmitoylethanolamide (Levagen+&lt;sup&gt;TM&lt;/sup&gt;) Compared to Ibuprofen for Reducing Headache Pain Severity and Duration in Healthy Adults: A Double-Blind, Parallel, Randomized Clinical Trial

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;

Research paper thumbnail of Increased bioavailability of curcumin using a novel dispersion technology system (LipiSperse®)

European journal of nutrition, Jul 4, 2018

Research paper thumbnail of 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...

Research paper thumbnail of Efficacy of Inferrin&lt;sup&gt;TM&lt;/sup&gt; and Lactoferrin on Symptoms of Irritable Bowel Syndrome in Otherwise Healthy Adults: A Randomised, Double-Blind, Placebo-Controlled Study

Food and Nutrition Sciences, 2023

Research paper thumbnail of An Exploratory Study of the Safety and Efficacy of a Trigonella foenum-graecum Seed Extract in Early Glucose Dysregulation: A Double-Blind Randomized Placebo-Controlled Trial

Pharmaceutics, Nov 14, 2022

Research paper thumbnail of A randomized controlled trial assessing the safety and efficacy of palmitoylethanolamide for treating diabetic-related peripheral neuropathic pain

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...

Research paper thumbnail of The Efficacy of Palmitoylethanolamide (Levagen+) on the Incidence and Symptoms of Upper Respiratory Tract Infection—A Double Blind, Randomised, Placebo-Controlled Trial

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...

Research paper thumbnail of Effectiveness of “Moro” Blood Orange Citrus sinensis Osbeck (Rutaceae) Standardized Extract on Weight Loss in Overweight but Otherwise Healthy Men and Women—A Randomized Double-Blind Placebo-Controlled Study

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...

Research paper thumbnail of A double-blind, randomised cross-over study to evaluate the absorption of a commercially available Ginkgo biloba extract compared to the liposomal extract Ginkgosome

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...

Research paper thumbnail of The Effect of a Dispersible Palmitoylethanolamide (Levagen+) Compared to a Placebo for Reducing Joint Pain in an Adult Population – A Randomised, Double-Blind Study

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.

Research paper thumbnail of The effect of an orally-dosed Caralluma Fimbriata extract on appetite control and body composition in overweight adults

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 =...

Research paper thumbnail of 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.

Research paper thumbnail of Increased Absorption of Palmitoylethanolamide Using a Novel Dispersion Technology System (LipiSperse)

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...

Research paper thumbnail of 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...

Research paper thumbnail of Palmitoylethanolamide for Sleep Disturbance. A Double-blind, Randomised, Placebo-controlled Interventional Study

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...

Research paper thumbnail of Trans-Resveratrol Oral Bioavailability in Humans Using LipiSperse™ Dispersion Technology

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...

Research paper thumbnail of Efficacy of topical palmitoylethanolamide (Levagen+) for the management of eczema symptoms: A double blind, comparator controlled, randomized clinical trial

Skin pharmacology and physiology, Feb 26, 2024

Research paper thumbnail of The Effect of Levagen+ (Palmitoylethanolamide) Supplementation on Symptoms of Allergic Rhinitis—A Double-Blind Placebo-Controlled Trial

Research paper thumbnail of Influence of a Specialized <i>Trigonella foenum-graecum</i> Seed Extract (Libifem), on Testosterone, Estradiol and Sexual Function in Healthy Menstruating Women, a Randomised Placebo Controlled Study

Phytotherapy Research, Apr 24, 2015

Research paper thumbnail of Libifem® (Trigonella foenum-graecum) in conjunction with exercise on muscle strength, power, endurance, and body composition in females aged between 25 and 45 years

Frontiers in sports and active living, Aug 11, 2023

Research paper thumbnail of Efficacy of Palmitoylethanolamide (Levagen+&lt;sup&gt;TM&lt;/sup&gt;) Compared to Ibuprofen for Reducing Headache Pain Severity and Duration in Healthy Adults: A Double-Blind, Parallel, Randomized Clinical Trial

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;

Research paper thumbnail of Increased bioavailability of curcumin using a novel dispersion technology system (LipiSperse®)

European journal of nutrition, Jul 4, 2018

Research paper thumbnail of 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...

Research paper thumbnail of Efficacy of Inferrin&lt;sup&gt;TM&lt;/sup&gt; and Lactoferrin on Symptoms of Irritable Bowel Syndrome in Otherwise Healthy Adults: A Randomised, Double-Blind, Placebo-Controlled Study

Food and Nutrition Sciences, 2023

Research paper thumbnail of An Exploratory Study of the Safety and Efficacy of a Trigonella foenum-graecum Seed Extract in Early Glucose Dysregulation: A Double-Blind Randomized Placebo-Controlled Trial

Pharmaceutics, Nov 14, 2022

Research paper thumbnail of A randomized controlled trial assessing the safety and efficacy of palmitoylethanolamide for treating diabetic-related peripheral neuropathic pain

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...

Research paper thumbnail of The Efficacy of Palmitoylethanolamide (Levagen+) on the Incidence and Symptoms of Upper Respiratory Tract Infection—A Double Blind, Randomised, Placebo-Controlled Trial

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...

Research paper thumbnail of Effectiveness of “Moro” Blood Orange Citrus sinensis Osbeck (Rutaceae) Standardized Extract on Weight Loss in Overweight but Otherwise Healthy Men and Women—A Randomized Double-Blind Placebo-Controlled Study

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...

Research paper thumbnail of A double-blind, randomised cross-over study to evaluate the absorption of a commercially available Ginkgo biloba extract compared to the liposomal extract Ginkgosome

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...

Research paper thumbnail of The Effect of a Dispersible Palmitoylethanolamide (Levagen+) Compared to a Placebo for Reducing Joint Pain in an Adult Population – A Randomised, Double-Blind Study

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.

Research paper thumbnail of The effect of an orally-dosed Caralluma Fimbriata extract on appetite control and body composition in overweight adults

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 =...

Research paper thumbnail of 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.

Research paper thumbnail of Increased Absorption of Palmitoylethanolamide Using a Novel Dispersion Technology System (LipiSperse)

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...

Research paper thumbnail of 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...

Research paper thumbnail of Palmitoylethanolamide for Sleep Disturbance. A Double-blind, Randomised, Placebo-controlled Interventional Study

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...

Research paper thumbnail of Trans-Resveratrol Oral Bioavailability in Humans Using LipiSperse™ Dispersion Technology

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...