- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01379911
Developing Methods for Completing Future Satiety Studies
Developing and Validating a Method for Satiety Studies
Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming food. Being able to effectively measure satiety is an important concept that has implications in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is recognized a useful strategy for weight management. Recently, the category of foods marketed as having satiating effects has seen significant growth and this trend is expected to continue. The purpose of this project is to develop and validate methods for assessing the degree of satiety induced by foods and natural health products using commercially available food products.
This trial will examine the effects of a commercially available yogurt (containing added protein and fibre) on self-reported satiety and hunger, as well as food intake in both controlled and uncontrolled settings.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Guelph, Ontario, 캐나다, N1G2W1
- Human Nutraceutical Research Unit, University of Guelph
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy women with regular hormonal contraceptive use, aged between 20 and 35 years
- BMI of 20.0-24.9 kg/m2
- Regular yogurt consumers (i.e. > 3 servings per week)
Exclusion Criteria:
- Taking any regular medications or herbal supplements other than a multivitamin or folic acid supplement.
- History of cardiovascular disease (including hypertension), diabetes, hypoglycemia, gum disease or any other medical condition
- Vegans or vegetarians who exclude dairy products
- Milk allergies or any other food allergies
- Anyone with known anaphylactic allergic reactions, food or otherwise
- Dislike or unwillingness to consume study foods
- Gastrointestinal disease or disorders, including Celiac disease, lactose intolerance, irritable bowel syndrome, etc.
- BMI <20.0 or > 25.0 kg/m2
- Current participation in diet/weight-loss programs and/or changes of > 5 kg body weight within the past 6 months
- Unusual dietary patterns (i.e. routinely skipping breakfast or other meals)
- Unusual sleep patterns (i.e. shift workers)
- High habitual intake of caffeinated beverages or alcohol
- Restrained or disinhibited eaters, defined by the Three Factor Eating Questionnaire
- Smokers
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Yogurt with added inulin
Yogurt with 6g of added inulin
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위약 비교기: Regular yogurt
Regular yogurt without added inulin
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self-reported ratings of satiety
기간: Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.
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The study consists of two trial days (pre- and post home consumption) per study period, one for each of 2 yogurts.
Each study visit involves a 4-hour stay at the HNRU.
The pre-study visit will be followed by a 6-day yogurt self-administration period where participants will consume the assigned yogurt at breakfast.
Thus, the acute satiety effects of the yogurts will be replicated in a controlled (laboratory) setting and evaluated over a 6-day period in an uncontrolled (home/lifestyle) environment.
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Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Food intake
기간: One week
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Study will include food and caloric intake over entire study day and for 6 days subsequent to initial study visit.
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One week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Amanda J Wright, Ph.D., University of Guelph
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .