- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00830999
Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance (DEV)
VLDL-triglyceride Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
연구 개요
상태
정황
상세 설명
Excess body fat and a sedentary lifestyle are associated with increased plasma triglyceride (TG) and apolipoprotein B-100 (apoB-100) concentrations, which are important risk factors for the development of cardiovascular disease.
Weight loss and endurance exercise improve plasma lipid and lipoprotein concentrations. However, the mechanisms responsible for this effect are largely unknown, and much uncertainty remains regarding the independent roles of dietary energy intake, exercise energy expenditure, and net energy balance in controlling plasma TG concentrations.
The main goal of this project, therefore, is to investigate the mechanisms by which acute alterations in energy balance, induced by diet and/or physical activity (endurance exercise), regulate very-low density lipoprotein (VLDL) metabolism.
Subjects will be asked to perform 3 separate trials. One of these will always be an "energy balance" trial that will act as the control trial for the other 2 trials they perform. Subjects will therefore be randomized to 2 different study arms.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University in Saint Louis
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- overweight and obese men
- normal to mild hypertriglyceridemia
Exclusion Criteria:
- Smoking
- Any medical condition other than increased body weight (e.g. diabetes, heart disease, etc.).
- Use of drugs known to affect lipid metabolism (e.g. statins, etc.).
- Regular exercise training.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Positive energy balance
Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials
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Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
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실험적: Energy balance with exercise
Comparison between an isocaloric diet without exercise and a hypercaloric diet with a sufficient amount of exercise performed to match the excess calories consumed resulting in both trials being in net energy balance.
|
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands but will perform 2 hours of exercise that will be sufficient to burn off the excess calories consumed resulting in subjects being in net energy balance.
|
실험적: Negative energy balance
Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials
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Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Subjects will consume over a 24 h period only 66% of the calories required to meet their energy demands such that they will be in a net negative calorie balance in this trial.
|
실험적: Negative energy balance with exercise
Comparison between consuming an isocaloric diet without exercise and consuming the same amount of calories as in the isocaloric trial but with exercise performed resulting in net negative energy balance in the exercise trial.
|
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Subjects will consume over a 24 hour period the same amount of calories as ingested in the isocaloric trial but will also perform 2 hours of exercise that will be sufficient to burn off a third of the calories they consumed during this day resulting in subjects being in net negative energy balance in this trial
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations
기간: After acute (24 hour) changes in energy intake and/or energy expenditure
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After acute (24 hour) changes in energy intake and/or energy expenditure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 secretion rates
기간: After acute (24 hour) changes in energy intake and/or energy expenditure
|
After acute (24 hour) changes in energy intake and/or energy expenditure
|
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Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 clearance rates from plasma
기간: After acute (24 hour) changes in energy intake and/or energy expenditure
|
After acute (24 hour) changes in energy intake and/or energy expenditure
|
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Plasma glucose concentration and turnover rate
기간: After acute (24 hour) changes in energy intake and/or energy expenditure
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After acute (24 hour) changes in energy intake and/or energy expenditure
|
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Plasma insulin concentration
기간: After acute (24 hour) changes in energy intake and/or energy expenditure
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After acute (24 hour) changes in energy intake and/or energy expenditure
|
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Plasma free fatty acid concentration and turnover rate
기간: After acute (24 hour) changes in energy intake and/or energy expenditure
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After acute (24 hour) changes in energy intake and/or energy expenditure
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Plasma glucose concentration
기간: During acute (24 hour) changes in energy intake and/or energy expenditure
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Measured hourly over the 24 h period.
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During acute (24 hour) changes in energy intake and/or energy expenditure
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Plasma insulin concentration
기간: During acute (24 hour) changes in energy intake and/or energy expenditure
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Measured hourly over the 24 h period.
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During acute (24 hour) changes in energy intake and/or energy expenditure
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Plasma free fatty acid concentration
기간: During acute (24 hour) changes in energy intake and/or energy expenditure
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Measured hourly over the 24 h period.
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During acute (24 hour) changes in energy intake and/or energy expenditure
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공동 작업자 및 조사자
간행물 및 유용한 링크
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. .
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