Diet and the prevention of cancer: Author's recommendations are not justified (original) (raw)
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Food and Chemical Toxicology, 2006
Postlaunch monitoring of functional foods can encompass monitoring of effectiveness under conditions of customary use. To this end, the effectiveness of phytosterol/-stanol enriched margarine consumption in free-living conditions was investigated with data from the Dutch "Doetinchem cohort study". In total, 4505 subjects (aged 26-70 years) were examined in 1994-1998 and re-examined during 1999-2003. A general and a food frequency questionnaire and non-fasting blood samples for total and HDL cholesterol determination were obtained. Subjects were stratified into phytosterol/-stanol enriched margarine users (n = 84) and non-users (n = 4421) based on the re-examination data, as these margarines were available on the Dutch market from 1999 onwards.
Exposure and effectiveness of phytosterol/-stanol-enriched margarines
European Journal of Clinical Nutrition, 2007
Background: Studies on effectiveness of phytosterol/-stanol-enriched margarines in the community have received low priority. For postlaunch monitoring purposes including risk-benefit analyses, it is needed to investigate both exposure and effectiveness of these margarines. Objective: To study the use and effectiveness of phytosterol/-stanol-enriched margarine. Design, setting and subjects: The study population consisted of 2379 subjects that participated in a community intervention study ('Hartslag Limburg') aged 28-76 years. In 1998 and 2003, blood samples for total and high-density lipoprotein (HDL) cholesterol were obtained. A general questionnaire and food frequency questionnaire (FFQ) were administered. From 1999 onwards, phytosterol/-stanol-enriched margarines were introduced on the Dutch market. On the basis of 2003 data, subjects were classified in users of (a) phytosterol/-stanol-enriched margarine, (b) cholesterol-lowering drugs, (c) the combination (both enriched margarine and drugs) and (d) neither enriched margarines nor cholesterol-lowering drugs. Results: Mean (7s.d.) daily intake of phytosterol-enriched margarine (n ¼ 99) and phytostanol-enriched margarine (n ¼ 16) was 1479 g. From 1998 to 2003, total serum cholesterol concentration changed significantly different among the four groups: in the combination users À2.0471.50 mmol/l (À29%), in cholesterol-lowering drug users À1.0971.17 mmol/l (À17%), in the enriched margarine users À0.2470.75 mmol/l (À4%) and in non-users þ 0.1070.72 mmol/l ( þ 2%)(Po0.05). Conclusion: Recommended doses are not consumed, but phytosterol/-stanol-enriched margarines can modestly reduce serum total cholesterol in the community. These margarines cannot equal the effect of cholesterol-lowering drugs, but may act additively. Further investigation of the health effects that may occur during simultaneous cholesterol lowering drugs and phytosterol-or -stanol-enriched margarines usage is important, as well as community education about the cholesterol lowering foods and drugs.
European Journal of Pharmacology, 2011
Objective: To assess the effectiveness (extent to which an intervention works in daily medical practice) of the use of phytosterol/phytostanol-enriched margarines to lower total and non-HDL cholesterol levels in users and non-users of statins. Design: Retrospective cohort study. Setting: Data were obtained from questionnaires on health and food intake from a population-based longitudinal cohort linked to pharmacy-dispensing records. Subjects: The analysis included 3829 men and women (aged 31-71 years) who were examined during 1998-2002 and re-examined at 5-year follow-up during 2003-2007. Results: Recommended doses of margarines were consumed by only 9 % of the subjects. Serum total cholesterol decreased by respectively 20?16 (95 % CI 20?26, 20?05) mmol/l, 21?40 (95 % CI 21?51, 21?30) mmol/l and 21?64 (95 % CI 21?91, 21
European Journal of Clinical Nutrition, 2000
Objective: To examine in humans the effects on serum lipids, lipoproteins and fat-soluble antioxidants of a daily consumption of 2.5 g plant stanols, consumed either once per day at lunch or divided over the three meals. Design: A randomized, double-blind, placebo-controlled, cross-over design. Subjects: Thirty-nine healthy normocholesterolemic or mildly hypercholesterolemic subjects participated. Interventions: Each subject consumed in random order; no plant stanols; 2.5 g plant stanols at lunch; and 2.5 g plant stanols divided over the three meals (0.42 g at breakfast, 0.84 g at lunch and 1.25 g at dinner, which is proportional to dietary cholesterol intake). Each period lasted 4 weeks. Plant stanols were esteri®ed with fatty acids from low erucic rapeseed oil (LEAR) and incorporated into margarines or shortenings. Results: Consumption of 2.5 g plant stanols at lunch results in a similar low-density lipoprotein (LDL)cholesterol-lowering ef®cacy compared to consumption of 2.5 g plant stanols divided over the three meals (À0.29 mmolal compared with the control period (P`0.001; 95% CI, À0.19 to À0.39 mmolal) for the once per day diet and À0.31 mmolal (P`0.001; 95% CI, À0.20 to À0.41 mmolal)) for the three times per day period). High-density Lipoprotein (HDL) cholesterol and triacylglycerol concentrations did not change. After standardization for LDL cholesterol, the sum of the most lipophylic hydrocarbon carotenoids (ie a-carotene, b-carotene and lycopene) in particular was slightly, though not signi®cantly, lowered by À0.017 + 0.018 mmolammol LDL cholesterol (P 0.307) after the once per day period and by À0.032 + 0.016 mmolammol LDL cholesterol (P 0.049) after the three times per day period. Conclusions: Our ®ndings suggest that for lowering LDL cholesterol concentrations it is not necessary to consume products rich in plant stanol ester at each meal or simultaneously with dietary cholesterol.
Nutrition, Metabolism and Cardiovascular Diseases, 2007
Background and aims: The use of phytosterol-enriched margarines (PEM) in patients at cardiovascular risk has not been thoroughly explored. We determined the proportion of users of PEM in a population at high cardiovascular risk, and their characteristics. In addition, the correlates of using at least 25 g/d of PEM were identified. Methods and results: Patients with at least two cardiovascular risk factors in addition to dyslipidemia (primary prevention) or with past cardiovascular disease (secondary prevention) were recruited by general practitioners (GPs). Baseline characteristics were collected from a computerized GP database linked to a survey. GPs recorded patterns of PEM use. First, users were compared with non-users. Then, analyses were conducted to identify characteristics of patients using PEM at a recommended dose (!25 g/d). Among 1631 patients with documented consumption, a minority used PEM (15.2%), and only 36.4% of consumers used it at recommended level. Overall, PEM users did not differ from non-users as to general characteristics, nor as to the level of cardiovascular risk in primary prevention. However, PEM users reported significantly more cardiovascular events among their parents (OR ¼ 1.4; 95% CI ¼ [1.0e1.9]). Consumers who used at least 25 g/d of PEM were more likely to be men (OR ¼ 3.1; 95% CI ¼ [1.6e5.8]), to be aged 60e74 Nutrition, Metabolism & Cardiovascular Diseases (2007) 17, 657e665 www.elsevier.com/locate/nmcd (OR ¼ 3.0; 95% CI ¼ [1.4e6.4]), or 75 or older (OR ¼ 4.0; 95% CI ¼ [1.5e10.6]). Again, no difference was observed regarding the level of cardiovascular risk. Conclusions: The level of use of PEM was low in this population of high cardiovascular risk patients. In addition, only a third of users consumed margarine at the recommended level. Our data suggest that pattern of use of PEM is not related to the level of cardiovascular risk. ª
European Journal of Clinical Nutrition, 2001
Objective: To measure the relative effects of each of four phytosterol ester-enriched low-fat foods (bread, breakfast cereal, milk and yoghurt) on serum lipids, plasma phytosterols and carotenoids. Design: Three research centres undertook a randomised, incomplete crossover, single-blind study consisting of four treatment periods of 3 weeks each, one of which was a control period. Each sterol-enriched test food provided 1.6 g/day of phytosterols as sterol esters. Setting: General Community. Subjects: In all 58, free-living men and women with mean age (s.d.) 54 (8) y, moderately elevated plasma total cholesterol 6.2 (0.7) mmol/l and body mass index 26.2 (3.0) kg/m 2 . Main outcome measures: Serum lipids, plasma phytosterols and carotenoids. Results: Serum total and LDL cholesterol levels were significantly lowered by consumption of phytosterol-enriched foods: milk (8.7 and 15.9%) and yoghurt (5.6 and 8.6%). Serum LDL cholesterol levels fell significantly by 6.5% with bread and 5.4% with cereal. They were both significantly less efficacious than sterol-enriched milk (Po0.001). Plasma sitosterol increased by 17-23% and campesterol by 48-52% with phytosterol-enriched milk and bread. Lipid-adjusted b-carotene was lowered by 5-10% by sterols in bread and milk, respectively. Conclusions: This is the first study to demonstrate that cholesterol-lowering effects of plant sterol esters may differ according to the food matrix. Plant sterols in low-fat milk was almost three times more effective than in bread and cereal. Despite phytosterolenriched cereal products resulting in lower serum cholesterol reductions compared to sterol-enriched milk, the detection of similar changes in plasma phytosterols demonstrated that such products still delivered and released phytosterols to the gut.
Atherosclerosis, 2013
Background: Consumption of plant sterols and plant stanols reduces low-density lipoprotein cholesterol (LDL-C) concentrations. At the same time, plasma plant sterol concentrations will increase after plant sterol consumption, but decrease after plant stanol consumption. In contrast to plant stanols, plant sterols can undergo oxidation and form oxyphytosterols. Findings from in vitro and animal studies suggest that oxyphytosterols might be atherogenic. Objective: The objective was to examine whether plant sterol and stanol consumption changes fasting plasma oxyphytosterol concentrations. Design: A randomized, double blind, cross-over study was performed in which 43 healthy subjects (18e70 years) consumed for 4 weeks a plant sterol-enriched (3.0 g/d of plant sterols), a plant stanol-enriched (3.0 g/d of plant stanols), and a control margarine separated by wash-out periods of 4 weeks. Oxyphytosterol concentrations were determined in BHT-enriched plasma via GCeMS. Results: Compared to control, serum LDL-C concentrations were reduced after plant sterol (À8.1%; p < 0.001) and plant stanol consumption (À7.8%; p < 0.001). Plant sterol consumption did not change plasma oxyphytosterol concentrations. On the other hand, intake of the plant stanol margarine reduced 7b-OH-campesterol by 0.07 ng/mL (w14%; p < 0.01) and by 0.07 ng/mL (w15%; p < 0.01) compared with the control and sterol margarines, respectively. When standardized for serum cholesterol, effects on these oxyphytosterols were comparable. In addition, plant stanol intake reduced cholesterolstandardized 7-keto-campesterol levels compared with plant sterol intake (p < 0.05). Conclusions: Daily consumption of a plant sterol-enriched margarine does not increase oxyphytosterol concentrations, while plant stanol consumption may reduce the concentrations of the oxidative plant sterol metabolites 7b-OH-campesterol and 7-keto-campesterol. This trial is registered at clinicaltrials.gov as NCT01559428.
European Journal of Clinical Nutrition, 1999
Objective: To investigate the dose-response relationship between cholesterol lowering and three different, relatively low intake levels of plant sterols (0.83, 1.61, 3.24 gad) from spreads. To investigate the effects on lipidsoluble (pro)vitamins. Design: A randomized double-blind placebo controlled balanced incomplete Latin square design using ®ve spreads and four periods. The ®ve study spreads included butter, a commercially available spread and three experimental spreads forti®ed with three different concentrations of plant sterols. Subjects: One hundred apparently healthy normocholesterolaemic and mildly hypercholesterolaemic volunteers participated. Interventions: Each subject consumed four spreads, each for a period of 3.5 week. Results: Compared to the control spread, total cholesterol decreased by 0.26 (CI: 0.15 ± 0.36), 0.31 (CI: 0.20 ± 0.41) and 0.35 (CI: 0.25 ± 0.46) mmolaL, for daily consumption of 0.83, 1.61 and 3.24 g plant sterols, respectively. For LDL-cholesterol these decreases were 0.20 (CI: 0.10 ± 0.31), 0.26 (CI: 0.15 ± 0.36) and 0.30 (CI: 0.20 ± 0.41). Decreases in the LDLaHDL ratio were 0.13 (CI: 0.04 ± 0.22), 0.16 (CI: 0.07 ± 0.24) and 0.16 (CI: 0.07 ± 0.24) units, respectively. Differences in cholesterol reductions between the plant sterol doses consumed were not statistically signi®cant. Plasma vitamin K1 and 25-OH-vitamin D and lipid standardized plasma lycopene and alpha-tocopherol were not affected by consumption of plant sterol enriched spreads, but lipid standardized plasma (alpha beta)-carotene concentrations were decreased by about 11 and 19% by daily consumption of 0.83 and 3.24 g plant sterols in spread, respectively. Conclusions: The three relatively low dosages of plant sterols had a signi®cant cholesterol lowering effect ranging from 4.9 ± 6.8%, 6.7 ± 9.9% and 6.5 ± 7.9%, for total, LDL-cholesterol and the LDLaHDL cholesterol ratio, respectively, without substantially affecting lipid soluble (pro)vitamins. No signi®cant differences in cholesterol lowering effect between the three dosages of plant sterols could be detected. This study would support that consumption of about 1.6 g of plant sterols per day will bene®cally affect plasma cholesterol concentrations without seriously affecting plasma carotenoid concentrations.
Atherosclerosis, 2001
Plant sterols may be a useful additive therapy in the treatment of hypercholesterolaemic patients. The purpose of this study was to determine the effect of a fat spread enriched with vegetable oil sterols on plasma lipid, lipoprotein and apolipoprotein concentrations. A randomised double blind placebo-controlled crossover trial with two consecutive periods of 8 weeks was conducted. 30 patients with heterozygous familial hypercholesterolaemia treated concurrently with an HMG-CoA reductase inhibitor (statin) and 32 patients with type IIa primary hypercholesterolaemia with a total cholesterol concentration \ 6.5 mmol/l not taking lipid-lowering drug therapy were recruited from a hospital lipid clinic. The active treatment was a fortified fat spread (25 g/day) providing 2.5 g of plant sterols. The control spread was indistinguishable in taste and appearance. Comparison at the end of the two 8-week trial periods showed a statistically significant reduction in total and LDL-cholesterol with use of the fortified spread but the results were confounded by a carry-over effect, which was partly explained by changes in the background diet. Because a carry-over effect was present, further analyses were restricted to the parallel arms of the first treatment period and were conducted on an intention to treat basis. After 4 weeks, LDL-cholesterol had decreased by 0.04 mmol/l ([0.8%] 95% confidence interval − 0.44-0.37 NS) in the placebo group and decreased by −0.76 mmol/l ([15.0%] 95% CI −1.03-− 0.48, PB 0.0001) in the active treatment group. After 8 weeks, the corresponding results were 0.0 mmol/l ([0.0%] 95% CI − 0.26-0.24 NS) and − 0.51 mmol/l ([10.0%] 95% CI −0.73-− 0.29 PB0.0001). There were no significant changes in apolipoprotein AI or B concentrations in the placebo group, but there was a small but statistically significant increase in apolipoprotein AI and a decrease in apolipoprotein B in the active treatment group. HDL cholesterol and triglyceride concentrations were unchanged. There was no difference in response between patients with statin-treated familial hypercholesterolaemia and patients with type IIa hyperlipoprotienaemia. We conclude that a fortified fat spread enriched with vegetable oil sterols reduces LDL-cholesterol by 10-15% with no difference in response between hypercholesterolaemic patients prescribed statins and those not taking lipid-lowering drug therapy.