Healthy Clinical Trial
Official title:
Acute Satiety and Energy Compensation After Consumption of a Pistachio Snack and Longer Term Consequences on Satiety, Anthropometry, and Body Composition After a Nutritional Intervention With Daily Consumption of the Pistachio Snack
The main goal of the study is to confirm that, due to their rich nutritional content in protein, polyunsaturated fatty acids, vitamins and minerals of interest (calcium and magnesium), the regular consumption of the recommended amount of pistachios by adult women will elicit appropriate satiety and compensation in the daily energy intake, and improve diet quality, anthropometry and body composition.
The expected endpoint is to demonstrate that the daily consumption of a snack of pistachios
by healthy women, as recommended in the next National Program for Nutrition and Health
(program PNNS, France), elicits adequate satiety and does not induce weight gain but rather
improves diet quality, body composition and body fat mass distribution (less abdominal fat).
The study will be a 16 weeks randomized controlled open trial, single-center, including two
parallel groups of 30 female participants (block randomization stratified on habitual energy
intake and initial body weight according to the consort-statement checklist).
The main working hypothesis is a demonstration of the "non inferiority" of the effects of the
pistachio intervention on body weight versus no snack consumption. The investigators
hypothesize that there will be no significant difference in body weight change due to
pistachios consumption. The two-sided 95% confidence interval on the intra-patient difference
(before minus after the pistachio intervention) will be provided through the appropriate
contrasts.
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