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| ID | Type | Description | Link |
|---|---|---|---|
| ID RCB : 20107-A031 | Registry Identifier | Agence Nationale de Sรฉcuritรฉ du Mรฉdicament (ANSM, France) | |
| APG01-0117 | Other Identifier | CreaBio-RA |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pistachio diet | Experimental | Incorporates 44 g (1 serving) of pistachios into a daily diet |
|
| Control | No Intervention | No pistachio consumption |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pistachio | Other | Dailly 44 g unsalted pistachios snack for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight in kg | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total daily energy intake | Total daily energy intake in kcal | 12 weeks |
| Appetite ratings | Appetite ratings measured on visual analogic scalls of 100 mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc FANTINO, MD, PhD, Pr. | Contact | +33 481 653 365 | marc.fantino@creabio-ra.com |
| Name | Affiliation | Role |
|---|---|---|
| Marc FANTINO, MD, PhD, Pr. | CreaBio Rhรดne-Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CreaBio Rhรดne-Alpes | Recruiting | Givors | Rhรดne | F-69700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31604062 | Derived | Fantino M, Bichard C, Mistretta F, Bellisle F. Daily consumption of pistachios over 12 weeks improves dietary profile without increasing body weight in healthy women: A randomized controlled intervention. Appetite. 2020 Jan 1;144:104483. doi: 10.1016/j.appet.2019.104483. Epub 2019 Oct 8. |
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Two parallel groups according a block randomization stratified on habitual energy intake and initial body weight (as in http://www.consort-statement.org/checklists/view/32--consort-2010/87-randomisation-type, ยง 8B). Randomisation: type).
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| 12 weeks |
| Body weight index | Body weight index in kg/m2 | 12 weeks |
| Body fat mass | Body fat mass in kg | 12 weeks |