- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01891617
Exercise Effects on Insulin, Gut Peptides, and Appetite (XFG)
The Exercise Effects on Appetite and Gut Peptides While on High-fat Diet
연구 개요
상세 설명
Specific aim: Determine whether a change in macronutrient composition from 60% carbohydrate and 25% fat to 30% carbohydrate and 45% fat is responsible by itself for suppression of hunger and increased secretory response of glucose-dependent insulinotropic hormone (GIP) and glucagon-like peptide-1 (GLP-1), or whether these changes depend on preceding exercise. We will measure (a) concentrations of plasma GIP and GLP-1 by chemiluminescent multiplex assay, (b) concentrations of plasma ancetaminophen to assess the gastric emptying rate, (c) concentrations of plasma insulin, and glucagon by radioimmunoassay, and glucose, ketone bodies, and free fatty acids with appropriate spectrophotometric methods, (d) hourly appetite responses with visual analog scale under two conditions: sedentary (SED) and exercise (EX).
Hypothesis: Hunger suppression and secretion of GIP and GLP-1 after the morning meal will be greater with slower gastric emptying rate when a meal consisting of 45% fat and 30% carbohydrate follows three hours after a 2-hour bout of moderate-intensity exercise than in the absence of exercise.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- Michigan Clinical Research Unit
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Postmenopausal status
- Age 50 to 65 years
- BMI between 20 and 30 kg/m2.
- Good health status (normotensive, fasting glucose < 100 mg/dl, , hematocrit > 32%, hemoglobin >12 mg/dl)
- Absence of restricted food intake
- Absence of endocrine and metabolic disorders requiring medication other than hormonally corrected hypothyroidism
- Absence of musculoskeletal disabilities that would prevent walking
Exclusion Criteria:
- Presence of endocrine and metabolic disease requiring medication, other than hormonally corrected hypothyroidism
- Presence of musculoskeletal disabilities that would prevent walking
- Smoking
- Active dieting
- Absence of listed inclusion criteria
- Unwillingness to follow study protocol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Exercise-high-fat diet
Two bouts of exercise followed by a high-fat meal
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Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
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실험적: Exercise-high-carbohydrate diet
Two bouts of exercise followed by a high-carbohydrate meal
|
Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
|
|
실험적: Sedentary-high-fat diet
Sedentary trial with two high-fat meals
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Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
|
|
실험적: Sedentary-high-carbohydrate diet
Sedentary trial with two high-carbohydrate meals
|
Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Plasma insulin concentration
기간: 36 hours
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Change in plasma insulin to two bouts of exercise followed by a high-carbohydrate or a high fat diet
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36 hours
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|
Plasma glucagon concentration
기간: 36 hours
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Changes in plasma glucagon concentration to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
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36 hours
|
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Plasma concentration of glucose-dependent insulinotropic peptide (GIP)
기간: 36 hours
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Changes in plasma concentration of glucose-dependent insulinotropic peptide (GIP)to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
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36 hours
|
|
Plasma concentration of free fatty acids
기간: 36 hours
|
Changes in plasma concentration of free fatty acidsto two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
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36 hours
|
|
Plasma concentration of beta-hydroxybutyrate
기간: 36 hours
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Changes in plasma concentration of beta-hydroxybutyrate to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
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36 hours
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Plasma glucose concentration
기간: 36 hours
|
Changes in plasma glucose concentration to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
|
daytime hourly appetite ratings
기간: 36 hours
|
Changes in daytime hourly appetite ratings to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
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36 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
기간: 36 hours
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Changes in plasma concentrations of glucagon-like peptide-1 (GLP-1)to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
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36 hours
|
|
Plasma concentrations of peptide tyrosine tyrosine (PYY)
기간: 36 hours
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Changes in plasma concentrations of peptide tyrosine tyrosine (PYY) to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Katarina Borer, PhD, University of Michigan
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
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