The present study was designed to evaluate the independent and interactive effects of a once-a-day yoghurt drink providing 2 g plant sterols/d and capsules providing 2 g fish oil n-3 long-chain (LC) PUFA/d on plasma lipids, apolipoproteins and LDL particle size. Following a 2-week run-in period, 200 mildly hypercholesterolaemic Indian adults aged 35-55 years were randomised into one of four groups of a 2 x 2 factorial, double-blind controlled trial. The 4-week treatments consisted of (1) control yoghurt drink and control capsules,(2) control yoghurt drink and fish oil capsules,(3) plant sterol-enriched yoghurt drink and control capsules, or (4) plant sterol-enriched yoghurt drink and fish oil capsules. Blood was drawn before and after the 4-week intervention. Changes in health status, lifestyle and dietary habits, and daily compliance were recorded. The main effects of plant sterols were a 4.5 % reduction in LDL-cholesterol and a 15 % reduction in TAG without a significant change in HDL-cholesterol. Overall, fish oil n-3 LC-PUFA did not significantly affect cholesterol concentrations but reduced TAG by 15 % and increased HDL-cholesterol by 5.4 %. The combination significantly lowered TAG by 15 % v. control. No significant interaction between plant sterols and n-3 LC-PUFA was observed on plasma cholesterol concentrations. In conclusion, once-a-day intake of 2 g plant sterols/d in a yoghurt drink, 2 g fish oil n-3 LC-PUFA/d in capsules, and their combination had beneficial effects on the lipid profile of mildly hypercholesterolaemic Indian adults. The potent hypotriacylglycerolaemic effect of plant sterols observed in the present study and this population warrants additional investigation.

Phytosterols (plant sterols and stanols) are well known for their LDL-cholesterol (LDL-C)-lowering effect. A meta-analysis of randomized controlled trials in adults was performed to establish a continuous dose-response relationship that would allow predicting the LDL-C-lowering efficacy of different phytosterol doses. Eighty-four trials including 141 trial arms were included. A nonlinear equation comprising 2 parameters (the maximal LDL-C lowering and an incremental dose step) was used to describe the dose-response curve. The overall pooled absolute (mmol/L) and relative (%) LDL-C-lowering effects of phytosterols were also assessed with a random effects model. The pooled LDL-C reduction was 0.34 mmol/L (95% CI:-0.36,-0.31) or 8.8%(95% CI:-9.4,-8.3) for a mean daily dose of 2.15 g phytosterols. The impacts of subject baseline characteristics, food formats, type of phytosterols, and study quality on the continuous dose-response curve were determined by regression or subgroup analyses. Higher baseline LDL-C concentrations resulted in greater absolute LDL-C reductions. No significant differences were found between dose-response curves established for plant sterols vs. stanols, fat-based vs. nonfat-based food formats and dairy vs. nondairy foods. A larger effect was observed with solid foods than with liquid foods only at high phytosterol doses (>2 g/d). There was a strong tendency (P = 0.054) towards a slightly lower efficacy of single vs. multiple daily intakes of phytosterols. In conclusion, the dose-dependent LDL-C-lowering efficacy of phytosterols incorporated in various food formats was confirmed and equations of the continuous relationship were established to predict the effect of a given phytosterol dose. Further investigations are warranted to investigate the impact of solid vs. liquid food formats and frequency of intake on phytosterol efficacy.

Objective:To test the dose-response effect on low-density lipoprotein cholesterol (LDL-c) of plant sterols (PS) from different sources in a low-fat spread.Methods:Dose responses of soybean oil (BO), tall oil (TO) and a mix of tall oil and rapeseed oil (TO/RP) as fatty acid esters were tested in a parallel design in free-living subjects recruited from the general community who had elevated cholesterol concentrations. Subjects received either control for 6 weeks or 1.6 g PS per day for 3 weeks, then 3.0 g/day for 3 weeks.Results:LDL-c was lowered significantly by consumption of 1.6 g/day of PS (-10.4%, range -7.3 to -11.4%). Increasing the dose to 3.0 g/day modestly reduced LDL-c concentrations further to -14.7%. TO, containing 78% sitosterol, produced an increase in serum sitosterol of 6.5 nmol/ml, while BO, containing only 27% campesterol, produced an increase in serum campesterol of 9.5 nmol/ml in 6 weeks. After PS withdrawal, serum sterols declined by 50% within 2 weeks.Conclusion:Different PS sources were equally effective in lowering serum LDL-c concentrations. The decrease in absolute concentrations of LDL-c was dependent on the baseline concentrations.European Journal of Clinical Nutrition advance online publication, 30 May 2007; doi:10.1038/sj.ejcn.1602814.

Objective:To determine the impact of intake occasion (with or without a meal), and product fat level on the cholesterol-lowering efficacy of a plant sterol (PS)-enriched (3 g/day) single-dose yoghurt drink.Design:Double-blind, randomized, placebo-controlled, parallel study with a 4 weeks run-in and 4 weeks intervention period.Setting:Subjects recruited from the general community.Subjects:A total of 184 moderate hypercholesterolaemic subjects (81 men and 103 women)(age 57+/-2 years) completed the study.Interventions:The study product was a 100-g single-dose yoghurt drink with or without added PS in the form of PS esters. The subjects were randomly assigned to one of five 4-week treatments:(i) drink A (0.1% dairy fat, 2.2% total fat) with a meal,(ii) drink A without a meal,(iii) drink B (1.5% dairy fat, 3.3% total fat) with a meal,(iv) drink B without a meal and (v) placebo drink with a meal.Results:LDL-cholesterol (LDL-C) was significantly lowered when the single-dose drink was taken with a meal independent of its fat content (drink A:-9.5%(P<0.001, 95% CI:-13.8 to -5.2); drink B:-9.3%(P<0.001, 95% CI:-13.7 to -4.9)) as compared to placebo. When consumed without a meal, LDL-C was also significantly decreased (drink A:-5.1%(P<0.05, 95% CI:-9.4 to -0.8); drink B:-6.9%(P<0.01, 95% CI:-11.3 to -2.5) as compared to placebo, however the effect was significantly smaller as compared to the intake with a meal.Conclusion:These results indicate that a PS-ester-enriched single-dose yoghurt drink effectively reduces LDL-C irrespective of the fat content of the product. A substantially larger decrease in serum cholesterol concentration was achieved when the single-dose drink was consumed with a meal emphasizing the importance of the intake occasion for optimal cholesterol-lowering efficacy.Sponsorship:Unilever Research and Development, Vlaardingen, The Netherlands.European Journal of Clinical Nutrition advance online publication, 19 October 2005; doi:10.1038/sj.ejcn.1602318.

OBJECTIVE: Although used by millions of overweight and obese consumers, there has not been a systematic assessment on the safety and effectiveness of a meal replacement strategy for weight management. The aim of this study was to review, by use of a meta- and pooling analysis, the existing literature on the safety and effectiveness of a partial meal replacement (PMR) plan using one or two vitamin/mineral fortified meal replacements as well as regular foods for long-term weight management. DESIGN: A PMR plan was defined as a program that prescribes a low calorie (>800<or=1600 kcal/day) diet whereby one or two meals are replaced by commercially available, energy-reduced product(s) that are vitamin and mineral fortified, and includes at least one meal of regular foods. Randomized, controlled PMR interventions of at least 3 months duration, with subjects 18 y of age or older and a BMI>or=25 kg/m(2), were evaluated. Studies with self-reported weight and height were excluded. Searches in Medline, Embase, and the Cochrane Clinical Trials Register from 1960 to January 2001 and from reference lists identified 30 potential studies for analysis. Of these, six met all of the inclusion criteria and used liquid meal replacement products with the associated plan. Overweight and obese subjects were randomized to the PMR plan or a conventional reduced calorie diet (RCD) plan. The prescribed calorie intake was the same for both groups. Authors of the six publications were contacted and asked to supply primary data for analysis. Primary data from the six studies were used for both meta- and pooling analyses. RESULTS: Subjects prescribed either the PMR or RCD treatment plans lost significant amounts of weight at both the 3-month and 1-year evaluation time points. All methods of analysis indicated a significantly greater weight loss in subjects receiving the PMR plan compared to the RCD group. Depending on the analysis and follow-up duration, the PMR group lost approximately 7-8% body weight and the RCD group lost approximately 3-7% body weight. A random effects meta-analysis estimate indicated a 2.54 kg (P<0.01) and 2.43 kg (P=0.14) greater weight loss in the PMR group for the 3-month and 1-y periods, respectively. A pooling analysis of completers showed a greater weight loss in the PMR group of 2.54 kg (P<0.01) and 2.63 kg (P<0.01) during the same time period. Risk factors of disease associated with excess weight improved with weight loss in both groups at the two time points. The degree of improvement was also dependent on baseline risk factor levels. The dropout rate for PMR and RCD groups was equivalent at 3 months and significantly less in the PMR group at 1 y. No reported adverse events were attributable to either weight loss regimen. CONCLUSION: This first systematic evaluation of randomized controlled trials utilizing PMR plans for weight management suggests that these types of interventions can safely and effectively produce significant sustainable weight loss and improve weight-related risk factors of disease.