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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Dailly 44 g unsalted pistachios snack for 12 weeks
CreaBio Rhône-Alpes
Givors, Rhône, France
RECRUITINGBody weight
Body weight in kg
Time frame: 12 weeks
Total daily energy intake
Total daily energy intake in kcal
Time frame: 12 weeks
Appetite ratings
Appetite ratings measured on visual analogic scalls of 100 mm
Time frame: 12 weeks
Body weight index
Body weight index in kg/m2
Time frame: 12 weeks
Body fat mass
Body fat mass in kg
Time frame: 12 weeks
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