- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01965210
The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function
2013년 10월 21일 업데이트: Isabella Lee, Swedish University of Agricultural Sciences
The Combined Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function After Short-Term Consumption
Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products.
The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein.
The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.
연구 개요
상태
완전한
정황
상세 설명
The short-term effects (up to 8 hours after intake) of dietary fibre and plant protein on subjective appetite and metabolism will be evaluated using a randomized cross-over study design.
Each participant will consume six different breakfasts on six different occasions separated by a 1 week wash-out period: three rye porridges supplemented with three different combinations of added fermentable dietary fibre and plant protein, two non-supplemented rye porridges differing in amount of rye and one wheat bread.
Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analog scale (VAS) every 30 min during an 8-hour period, starting 30 min before breakfast.
The concentration of hydrogen and methane in the breath, as indicators of bacterial fermentation of dietary fibre, will be measured every hour.
Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose and hormone levels.
The metabolic profile in the blood will be assessed as well as products from bacterial fermentation of dietary fibre, such as short chain fatty acids.
Gastric emptying rate will also be evaluated using paracetamol as an indicator.
Hormonal responses, changes in the metabolome and fermentation products will be related to subjective appetite and to differences in composition of the breakfasts.
연구 유형
중재적
등록 (실제)
22
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Uppsala, 스웨덴, SE-751 85
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Women must be post-menopausal or habitually take hormonal contraceptives
- Habitual breakfast eaters
Exclusion Criteria:
- Non-contraceptive use among pre-menopausal women
- Pregnancy, lactation or wishing to become pregnant during the study period
- Dieting
- Weightloss
- Eating disorder
- Hyperglycemic
- Hyperinsulinemic
- Thyroid disease
- Metabolic issues
- Diabetes
- Physical or psychological problems eating
- Food intolerances/allergies to foods included in the study
- Vegetarians
- Intolerance/allergy to paracetamol
- Heavy smokers
- Recent or concurrent participation in an intervention research study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Rye + high dose inulin + low dose gluten
Rye porridge supplemented with a high dose of the fermentable dietary fibre inulin and low dose of the plant protein gluten.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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실험적: Rye + equal doses of inulin & gluten
Rye porridge supplemented with equal doses of the fermentable dietary fibre inulin and the plant protein gluten.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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|
실험적: Rye + low dose inulin + high dose gluten
Rye porridge supplemented with a low dose of the fermentable dietary fibre inulin and a high dose of the plant protein gluten.
|
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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실험적: Large non-supplemented rye
Large portion of rye porridge without supplements.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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실험적: Small non-supplemented rye
Small portion of rye porridge without supplements.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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활성 비교기: Refined wheat bread
Refined wheat bread.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective appetite profiles
기간: 8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)
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Subjective feelings of appetite (satiety, hunger and desire to eat) are assessed by visual analogue scale (VAS) (in total 18 measurements).
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8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Breath hydrogen and methane response
기간: 8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)
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Measurements of the concentration of breath hydrogen and methane(in total 10 measurements).
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8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)
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Gastric emptying rate
기간: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Paracetamol (1 g) was taken with breakfast.
The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Glucose and hormonal response
기간: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), glucose-dependent insulino-tropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), leptin and ghrelin are measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Metabolic profiles
기간: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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The flux of nutrients is measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Products from bacterial fermentation of dietary fibre
기간: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Products from bacterial fermentation of dietary fibre are measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Ad libitum food intake
기간: 8 h after breakfast (480 min)
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Energy intakes will be assessed from the ad libitum dinner in order to validate subjective appetite measurements.
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8 h after breakfast (480 min)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Rikard K Landberg, Ass. Prof., Swedish University of Agricultural Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 3월 1일
기본 완료 (실제)
2013년 8월 1일
연구 완료 (실제)
2013년 8월 1일
연구 등록 날짜
최초 제출
2013년 9월 16일
QC 기준을 충족하는 최초 제출
2013년 10월 15일
처음 게시됨 (추정)
2013년 10월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 10월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 10월 21일
마지막으로 확인됨
2013년 10월 1일
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. .