- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02215603
Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults
Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Thus, our study aims to comprehensively investigate the effects of disrupting prolonged sitting with different physical activity protocols on metabolic risk factors in sedentary males.
Ten sedentary males will take part in this randomized cross-over trial consisting of four 27-h conditions. All conditions will be identical except for the physical activity: prolonged sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout +interval standing intervention (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and cytokines will be determined.
The investigators expect that disrupting prolonged sitting with intermittent standing and a moderate-exercise bout will positively affect the metabolic profile of the participants. Furthermore, we will investigate if combined, these strategies will have an additive effect.
연구 개요
상태
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2100
- 모병
- Centre of Inflammation and Metabolism
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연락하다:
- Inge Holm
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수석 연구원:
- Bente Pedersen, PhD
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부수사관:
- Fabiana Benatti, PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Males,
- age 25-55 y,
- BMI >18 and <35 kg/m2
Exclusion Criteria:
- Clinically diagnosed diabetes,
- dyslipidaemia,
- hypertension,
- use of glucose- and/or lipid-lowering medication,
- smoking,
- evidence of thyroid, liver, lung, heart or kidney disease,
- non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the last 4 months,
- VO2max levels above the considered average fitness according to age,
- contraindication to increased levels of physical activity.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Prolonged sitting
9 h of prolonged sitting
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실험적: Prolonged sitting + interval standing bouts
Stand bout for 15-min every 30 minutes during the 9 hours of sitting
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실험적: Moderate exercise bout + Prolonged sitting
30-min moderate-intensity exercise bout followed by 8 h of sitting
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실험적: Moderate exercise bout + Prolonged sitting +Standing bouts
30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Area under the curve of glucose and insulin postprandial responses
기간: 27 h
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Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Glucose levels
기간: 27 hours
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Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours.
Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l).
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27 hours
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Area under the curve of lipid postprandial responses
기간: 27 h
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Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Area under the curve of cytokine postprandial responses
기간: 27 h
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Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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 연구와 관련된 용어
기타 연구 ID 번호
- ProlongedSitting
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