Pistachio Intake, Satiety and Body Weight Control in Healthy Adult Women (APIS)

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Pistachio

Detailed Description

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône
    • Givors, Rhône, France, F-69700
      • Recruiting
      • CreaBio Rhône-Alpes
      • Contact: Marc Fantino, MD, PhD, Pr; Phone Number: +33 481 653 365; Email: marc.fantino@creabio-ra.com
      • Principal Investigator: Marc Fantino, MD, PhD, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Healthy women;
2. Age: lower age limit 18 years, upper age limit: 50 years (included);
3. Body Mass Index: lower limit 19 kg/m²; upper limit 29.9 kg/m²; weight stable within ± 2 kg in the last 3 months;
4. Habitual energy intake, as indicated by an initial intake report (diary method, three days) within the 95% confidence interval (CI) of the habitual energy intake of a similar population (as provided by internal reference data collected by CREABio-RA from previous studies in similar conditions);
5. Participant not pregnant, not presently breast feeding or having breastfed in the last 3 months, and not planning to become pregnant during the study (negative pregnancy test at inclusion or morning of V1);
6. Pre-menopausal participant on effective contraception since at least 3 months (regular 28-day cycle) and who agree to continue their contraception throughout the study;
7. Participant registered with the French Social Security;
8. participant having signed informed consent

Exclusion Criteria:

1. Subject under legal protection or deprived of liberty by judicial or administrative decision.
2. Currently diagnosed somatic pathology;
3. On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months;
4. Major psychiatric disorder, particularly eating disorders as defined by the DSM-V;
5. High level of "Restrained Eating" or "Disinhibition", as revealed by the TFEQ or similar questionnaire;
6. Strong initial dislike of nuts, specially pistachios, as revealed by questioning about food habits initial dietary questionnaire;
7. Habitual consumption of pistachios as revealed by the 3-d intake report (more than twice a week);
8. Participants smoking more than 10 cigarettes per day or planning to stop smoking in the next 3 months;
9. Currently pregnant, lactating (as specified in article L1121-5 of the Public Health Code) or less than 6 month post-partum;
10. Any kind of food allergy, especially allergies or intolerance to nuts;
11. Participant not capable of understanding the constraints of the study, who does not agree to abide, and/or unable to communicate normally with investigators;
12. Person currently participating in another clinical study, or having used up her annual entitlement to compensation for participation in biomedical studies (4500 €).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pistachio diet; Incorporates 44 g (1 serving) of pistachios into a daily diet	Other: Pistachio; Dailly 44 g unsalted pistachios snack for 12 weeks
No Intervention: Control; No pistachio consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight in kg	12 weeks

Secondary Outcome Measures

Outcome Measure	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	12 weeks
Body weight index	Body weight index in kg/m2	12 weeks
Body fat mass	Body fat mass in kg	12 weeks

Collaborators and Investigators

• Sponsor: Rene' Yamashiro
• Investigators: Principal Investigator: Marc FANTINO, MD, PhD, Pr., CreaBio Rhône-Alpes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: April 22, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Body mass index; Energy intake; Fat mass; Human subjects; Pistachio snack
• Other Study ID Numbers: APIS; ID RCB : 20107-A031 (Registry Identifier: Agence Nationale de Sécurité du Médicament (ANSM, France)); APG01-0117 (Other Identifier: CreaBio-RA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No