- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03917810
Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
Dietary sugar and carbohydrate intakes will be manipulated for 3 days in a randomised crossover design. All food will be provided. Free-living physical activity energy expenditure will be measured using combined heart rate and accelerometry. Metabolic and appetite/mood responses to 3 days on each diet will be measured.
Each participant will undergo 3 days of each diet:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
연구 개요
상세 설명
Guidelines calling for dietary free sugars to be reduced have been formulated from evidence that diets high in sugar are associated with high energy intake. In theory, by reducing the intake of sugars, calorie surplus will be reduced and energy balance will be maintained. However, when referring to interventions/behaviours that influence energy balance, both sides of the energy balance equation need to be considered. Alterations in nutrients may influence aspects of energy expenditure, not solely energy intake, and this may have implications for the efficacy of guidelines seeking to influence energy intake.
It is important to consider energy expenditure in the context of health. The most variable component of energy expenditure between individuals is physical activity energy expenditure (PAEE), which varies from ~600-2100 kcal per day in men of a similar demographic. Current guidelines do not regard the effect that changing dietary sugar might have on PAEE and therefore total energy expenditure.
Furthermore, there is increasing interest in restricting overall carbohydrate intake to treat metabolic disease or achieve ketogenesis. Very little is known about nutrition-physical activity interactions with this type of intervention.
This study will prescribe 3 diets to healthy males for 3 days in a randomised crossover design, where each participant will consume each of the diets. All food will be prepared and provided by the study team. The diets are as follows:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Somerset
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Bath, Somerset, 영국, BA2 7AY
- University of Bath
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Male
- Able and willing to provide informed consent and safely comply with study procedures
- No anticipated changes in physical activity during the study (e.g. holidays)
Exclusion Criteria:
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)•Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (±3%)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: MODSUG
Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat
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다량 영양소 구성(특히 탄수화물의 유형 및/또는 양)이 조작됩니다.
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실험적: LOWSUG
Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat
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다량 영양소 구성(특히 탄수화물의 유형 및/또는 양)이 조작됩니다.
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실험적: LOWCHO
Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat
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다량 영양소 구성(특히 탄수화물의 유형 및/또는 양)이 조작됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical activity energy expenditure (kj/day or kcal/day)
기간: 3 days
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Physical activity energy expenditure measured using individually-calibrated combined heart rate and accelerometry (kj/day or kcal/day)
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3 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time spent in different physical activity intensities (MET categories) (minutes)
기간: 3 days
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Time spent in different physical activity intensities (MET categories) (minutes) using individually-calibrated combined heart rate and accelerometry
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3 days
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Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day)
기간: 3 days
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Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day) using individually-calibrated combined heart rate and accelerometry
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3 days
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Energy expended in the postprandial period (kJ or kcal)
기간: 3 days
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Energy expended in the postprandial period (kJ or kcal) measured using individually-calibrated combined heart rate and accelerometry
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3 days
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Fasting blood glucose concentrations
기간: 3 days
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Measures of blood glucose concentrations pre- and post-intervention.
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3 days
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Fasting blood insulin concentrations
기간: 3 days
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Measures of blood insulin concentrations pre- and post-intervention.
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3 days
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Fasting blood triglyceride concentrations
기간: 3 days
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Measures of blood triglyceride concentrations pre- and post-intervention.
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3 days
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Fasting blood non-esterified fatty acid concentrations
기간: 3 days
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Measures of blood non-esterified fatty acid concentrations pre- and post-intervention.
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3 days
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Fasting blood lactate concentrations
기간: 3 days
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Measures of blood lactate concentrations pre- and post-intervention.
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3 days
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Fasting blood beta-hydroxybutyrate concentrations
기간: 3 days
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Measures of blood beta-hydroxybutyrate concentrations pre- and post-intervention.
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3 days
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Fasting blood leptin concentrations
기간: 3 days
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Measures of blood leptin concentrations pre- and post-intervention.
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3 days
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Fasting blood fibroblast growth factor-21 concentrations
기간: 3 days
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Measures of blood fibroblast growth factor-21 concentrations pre- and post-intervention.
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3 days
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Fasting blood total cholesterol concentrations
기간: 3 days
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Measures of blood total cholesterol concentrations pre- and post-intervention.
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3 days
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Fasting blood high density lipoprotein concentrations
기간: 3 days
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Measures of blood high density lipoprotein concentrations pre- and post-intervention.
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3 days
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Fasting blood low density lipoprotein concentrations
기간: 3 days
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Measures of blood low density lipoprotein concentrations pre- and post-intervention.
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3 days
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Food preference ratings
기간: 3 days
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Food preference ratings determined by computer task measured pre- and post-intervention
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3 days
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Subjective appetite and mood ratings
기간: 3 days
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Measured by 0-100 mm visual analogue scales measured pre- and post-intervention
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3 days
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Blood pressure
기간: 3 days
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Blood pressure using an automated sphygmomanometer pre- and post-intervention
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3 days
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
- Smith HA, Gonzalez JT, Thompson D, Betts JA. Dietary carbohydrates, components of energy balance, and associated health outcomes. Nutr Rev. 2017 Oct 1;75(10):783-797. doi: 10.1093/nutrit/nux045.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .