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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rhône
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Givors, Rhône, 프랑스, F-69700
- 모병
- CreaBio Rhône-Alpes
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연락하다:
- Marc Fantino, MD, PhD, Pr
- 전화번호: +33 481 653 365
- 이메일: marc.fantino@creabio-ra.com
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수석 연구원:
- Marc Fantino, MD, PhD, Pr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy women;
- Age: lower age limit 18 years, upper age limit: 50 years (included);
- Body Mass Index: lower limit 19 kg/m²; upper limit 29.9 kg/m²; weight stable within ± 2 kg in the last 3 months;
- 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);
- 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);
- 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;
- Participant registered with the French Social Security;
- participant having signed informed consent
Exclusion Criteria:
- Subject under legal protection or deprived of liberty by judicial or administrative decision.
- Currently diagnosed somatic pathology;
- On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months;
- Major psychiatric disorder, particularly eating disorders as defined by the DSM-V;
- High level of "Restrained Eating" or "Disinhibition", as revealed by the TFEQ or similar questionnaire;
- Strong initial dislike of nuts, specially pistachios, as revealed by questioning about food habits initial dietary questionnaire;
- Habitual consumption of pistachios as revealed by the 3-d intake report (more than twice a week);
- Participants smoking more than 10 cigarettes per day or planning to stop smoking in the next 3 months;
- Currently pregnant, lactating (as specified in article L1121-5 of the Public Health Code) or less than 6 month post-partum;
- Any kind of food allergy, especially allergies or intolerance to nuts;
- Participant not capable of understanding the constraints of the study, who does not agree to abide, and/or unable to communicate normally with investigators;
- Person currently participating in another clinical study, or having used up her annual entitlement to compensation for participation in biomedical studies (4500 €).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Pistachio diet
Incorporates 44 g (1 serving) of pistachios into a daily diet
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Dailly 44 g unsalted pistachios snack for 12 weeks
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간섭 없음: Control
No pistachio consumption
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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체중
기간: 12주
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체중(kg)
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12주
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total daily energy intake
기간: 12 weeks
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Total daily energy intake in kcal
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12 weeks
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Appetite ratings
기간: 12 weeks
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Appetite ratings measured on visual analogic scalls of 100 mm
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12 weeks
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Body weight index
기간: 12 weeks
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Body weight index in kg/m2
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12 weeks
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Body fat mass
기간: 12 weeks
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Body fat mass in kg
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12 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Marc FANTINO, MD, PhD, Pr., CreaBio Rhône-Alpes
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- APIS
- ID RCB : 20107-A031 (레지스트리 식별자: Agence Nationale de Sécurité du Médicament (ANSM, France))
- APG01-0117 (기타 식별자: CreaBio-RA)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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