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. (4) 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.Since 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.
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 (4800r1600 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 BMIZ25 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 B7-8% body weight and the RCD group lost B3-7% body weight. A random effects meta-analysis estimate indicated a 2.54 kg (Po0.01) and 2.43 kg (P ¼ 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 (Po0.01) and 2.63 kg (Po0.01) 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.
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. non fat-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.
Multiple micronutrient supplementation may be associated with a marginal increase in fluid intelligence and academic performance in healthy schoolchildren but not with crystallized intelligence. More research is required, however, before public health recommendations can be given.
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