- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02075788
Millet Products Study - Investigation of Glycemic Index and Satiety
연구 개요
상태
상세 설명
The purpose of this study is to investigate how millet incorporation into different baked product types (i.e. an extruded snack versus a biscuit) influences glycemic response and satiety.
This project will examine the effect of millet, on glycemic response and satiety. To determine the effect of product matrix and processing methods, testing will be done using an extruded snack, porridge, a couscous-like product and a biscuit.
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
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:
- Men, age 19-40, non-smoking
- Normal fasting plasma glucose (<5.6 mmol/L but not below 3.6 mmol/L)
- Normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. <7.8 mmol/L but not below 3.6 mmol/L)
- BMI ranging from 18.5 to 29.9 kg/m2
Exclusion Criteria:
- Insulin resistance (IR) will be calculated from fasting glucose and insulin values using the Homeostasis Assessment Model 2 (HOMA2). A HOMA2-IR value of greater than 1.0 will be considered indicative of insulin resistance (Levy J.C. et al. 1998).
- Regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week
- Smoking or use of recreational drugs
- Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
- Very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings.
- Restrained eater as defined by the questionnaire at screening (Three Factor Eating Questionnaire, Stunkard et al.,1985)
- Food neophobic defined by Food Neophobia Scale questionnaire
- Unusual sleep patterns or irregular breakfast consumption
- Recent (i.e. >4 kg in previous 3 months) or intended weight loss or gain
- Food allergies or any life-threatening allergy (food or otherwise)
- Inflammatory bowel disease or other gastrointestinal disorders
- Use of drugs which influence carbohydrate metabolism
- Training or elite athletes
- Inability to adhere to Study Protocols
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Commercial white bread
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
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실험적: Millet based products (porridge etc.)
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
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활성 비교기: Corn based products (porridge etc.)
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Determination of glycemic index based on collection of capillary plasma glucose
기간: Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
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Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Self reported ratings of satiety
기간: Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
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Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
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공동 작업자 및 조사자
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. .