Can a small-changes approach help address the obesity epidemic? A report of the Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council.

The continued rise in obesity rates in most countries suggests that current programs and initiatives designed to combat obesity have not been successful in reversing the obesity epidemic. Obesity rates are increasing because of a gradual weight gain in most populations. There has been little long-term success in treating established obesity through lifestyle change, perhaps because of the large permanent changes in diet and physical activity required to keep weight off. An alternative strategy to address the obesity epidemic involves not focusing on weight loss but promoting small changes in diet and physical activity to initially prevent further weight gain. With the use of this strategy, obesity rates could first be stabilized in most populations and then, over time, decrease gradually. Supporting data show that small reductions in conscious energy intake and increases in physical activity can reduce excessive weight gain. The opportunity exists to use the small-changes approach to bring different stakeholders together to create a national initiative to address the global epidemic of obesity. The Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council believe that a small-changes framework, aimed at helping people make conscious small changes in lifestyle behaviors, in combination with efforts by the private sector to gradually "ratchet down" some of the environmental factors that have contributed to excessive energy intake and the declining rates of physical activity, can be successful in reducing obesity rates. Such an initiative would benefit from the support of educational and social marketing campaigns developed with governmental input and support.

Safety and antioxidant activity of a pomegranate ellagitannin-enriched polyphenol dietary supplement in overweight individuals with increased waist size.

The consumption of pomegranate juice (PJ), a rich source of antioxidant polyphenols, has grown tremendously due to its reported health benefits. Pomegranate extracts, which incorporate the major antioxidants found in pomegranates, namely, ellagitannins, have been developed as botanical dietary supplements to provide an alternative convenient form for consuming the bioactive polyphenols found in PJ. Despite the commercial availability of pomegranate extract dietary supplements, there have been no studies evaluating their safety in human subjects. A pomegranate ellagitannin-enriched polyphenol extract (POMx) was prepared for dietary supplement use and evaluated in two pilot clinical studies. Study 1 was designed for safety assessment in 64 overweight individuals with increased waist size. The subjects consumed either one or two POMx capsules per day providing 710 mg (435 mg of gallic acid equivalents, GAEs) or 1420 mg (870 mg of GAEs) of extracts, respectively, and placebo (0 mg of GAEs). Safety laboratory determinations, including complete blood count (CBC), chemistry, and urinalysis, were made at each of three visits. Study 2 was designed for antioxidant activity assessment in 22 overweight subjects by administration of two POMx capsules per day providing 1000 mg (610 mg of GAEs) of extract versus baseline measurements. Measurement of antioxidant activity as evidenced by thiobarbituric acid reactive substances (TBARS) in plasma were measured before and after POMx supplementation. There was evidence of antioxidant activity through a significant reduction in TBARS linked with cardiovascular disease risk. There were no serious adverse events in any subject studied at either site. These studies demonstrate the safety of a pomegranate ellagitannin-enriched polyphenol dietary supplement in humans and provide evidence of antioxidant activity in humans.

Number of days, number of subjects, and sources of variation in longitudinal intervention or crossover feeding trials with multiple days of measurement.

Dietary studies are often conducted as longitudinal intervention or crossover trials using multiple days of measurement on each subject during each of several measurement periods, and determining the required numbers of days and subjects is important in designing these studies. Linear mixed statistical models were used to derive equations for precision, statistical power and sample size (number of days and number of subjects) and to obtain estimates of between-subject, period-to-period, and day-to-day variation needed to apply the equations. Two cohorts of an on-going exercise intervention study, and a crossover study of Olestra, each with 14 d of measurement/subject per period, were used to obtain estimates of variability for energy and macronutrient intake. Numerical examples illustrate how the equations for calculating the number of days or number of subjects are applied in typical situations, and sample SAS code is given. It was found that between-subject, period-to-period, and day-to-day variation all contributed significantly to the variation in energy and macronutrient intake. The ratio of period-to-period and day-to-day standard deviations controls the trade-off between the number of days and the number of subjects, and this remained relatively stable across studies and energy and macronutrient intake variables. The greatest gains in precision were seen over the first few measurement days. Greater precision and fewer required days were noted in the study (Olestra) that exerted greater control over the subjects and diets during the feeding protocol.