Appetite control: methodological aspects of the evaluation of foods.

This report describes a set of scientific procedures used to assess the impact of foods and food ingredients on the expression of appetite (psychological and behavioural). An overarching priority has been to enable potential evaluators of health claims about foods to identify justified claims and to exclude claims that are not supported by scientific evidence for the effect cited. This priority follows precisely from the principles set down in the PASSCLAIM report. The report allows the evaluation of the strength of health claims, about the effects of foods on appetite, which can be sustained on the basis of the commonly used scientific designs and experimental procedures. The report includes different designs for assessing effects on satiation as opposed to satiety, detailed coverage of the extent to which a change in hunger can stand alone as a measure of appetite control and an extensive discussion of the statistical procedures appropriate for handling data in this field of research. Because research in this area is continually evolving, new improved methodologies may emerge over time and will need to be incorporated into the framework. One main objective of the report has been to produce guidance on good practice in carrying out appetite research, and not to set down a series of commandments that must be followed.

Dose-response effects of different plant sterol sources in fat spreads on serum lipids and C-reactive protein and on the kinetic behavior of serum plant sterols.

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.

Intake occasion affects the serum cholesterol lowering of a plant sterol-enriched single-dose yoghurt drink in mildly hypercholesterolaemic subjects.

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.

Weight management using a meal replacement strategy: meta and pooling analysis from six studies.

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 (>800or=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.