- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04720950
The Impact of Morning or Evening Exercise on Food Intake (TIME-Ex-Ulster)
The Impact of Morning or Evening Exercise on Total Energy Intake and Food Preference in Non-Exercising Adults.
The beneficial effects of regular exercise on both physical and mental health are widely known; it is a pivotal component in the treatment and prevention of many metabolic disorders, including obesity. Exercise facilitates weight management, not only by increasing energy expenditure but through its effect on appetite regulation and, therefore, energy intake.
Multiple factors influence the effect of exercise on appetite regulation including body fat , gender, intensity and duration of exercise and levels of habitual physical activity . However, recently interest has grown around the impact time-of-day of exercise may have on appetite regulation . Subjective feelings of hunger follow a strong diurnal pattern, with feelings of hunger peaking in the evening and appearing lowest in the morning . Evening energy intake has been associated with increased total energy intake and body mass index Evening exercise could potentially counteract or lessen the evening hunger sensations and therefore reduce evening and total energy intake. The aim of this study is to investigate any changes in total energy intake, distribution of energy intake, and food preference on the day of and 24 -hours after a bout of moderate-intensity exercise completed in the morning or evening in a group of physically inactive adults. A total sample of 12 physically inactive adults aged 18-60 will be recruited on to the study. The study will take the form of a two-armed randomised controlled crossover trial consisting of two 48-hr overnight stays in the Human Intervention Studies Unit (HISU) at Ulster University, Coleraine, Northern Ireland. The participant information sheet will focus on the effect of morning and evening exercise on ambulatory blood pressure and exercise-induced feeling states to prevent the participants' knowledge of the true purpose of the study from influencing their feeding behaviours. Ambulatory blood pressure will be monitored for at least 24 hours after the exercise session and participants will be asked to complete questionnaires of exercise induced feeling states immediately before and after each exercise session. Participants will be briefed on the true purpose of the study following the study completion. During the visits, participants will be asked to perform 1 hour of exercise at 70% of their maximal heart rate on a motorised treadmill between either 0800-1000 or 1800-2000 on the first full day of the study appointment. Food will be provided ad libitum for the duration of the study. All food intake will be noted and covertly weighed and directly observed through security cameras in the HISU dining room and lounge areas to measure food-related behaviours, such as grazing or bingeing. A 24 hour dietary recall will be conducted at the end of each study appointment to validate recall against observed intake.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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N.Ireland
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Coleraine, N.Ireland, 영국, BT52 1SA
- 모병
- Human Intervention Studies Unit
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연락하다:
- Ruth K Price
- 전화번호: +442870123878
- 이메일: rk.price@ulster.ac.uk
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연락하다:
- Julie J Sittlington
- 전화번호: +442870124101
- 이메일: jj.sittlington@ulster.ac.uk
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Does not exercise regularly (as determined by International Physical Activity Questionnaire (IPAQ) short form.
- Able to perform 1 hour of moderate-intensity exercise on a treadmill.
Exclusion Criteria:
- Pregnancy/ lactation.
- Have significant dysphagia, gastric outlet obstruction, or any other factor which prevents the consumption of a meal.
- Have a significant food allergy or dietary restriction.
- Have a systemic or gastrointestinal condition that may affect food intake or preference.
- Taking medication or supplements that affect energy intake or appetite.
- Taking medication that affects blood pressure or heart rate.
- Have an irregular sleep or shift work patterns.
- Travel across > one time zone in the last month.
- Fitted with pacemaker
- Smokes or uses vaping products
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Morning exercise
1 hour of exercise completed between 0800-1000
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1 hour of exercise on a motorised treadmill at 70% maximal heart rate
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실험적: Evening exercise
1 hour of exercise completed between 1800-2000
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1 hour of exercise on a motorised treadmill at 70% maximal heart rate
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total energy intake
기간: Over 48 hours
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Covertly weighed food intake (kJ/day)
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Over 48 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distribution of energy intake across the day
기간: Over 48 hours
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Covertly weighed food intake (kJ/eating epochs)
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Over 48 hours
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Percentage energy intake from macronutrients
기간: Over 48 hours
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% energy intake from fat, total carbohydrates, sugar, protein and fibre
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Over 48 hours
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Basal metabolic rate
기간: Over 8 minutes after waking
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By indirect calorimetry
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Over 8 minutes after waking
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Ambulatory blood pressure
기간: Over 24 hours
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Measured using Spacelabs 90217 ambulatory monitors
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Over 24 hours
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Exercise induced feelings state.
기간: Change over 1 hour (pre exercise to post exercise)
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Measured using The Exercise Induced Feeling Inventory (EFI)
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Change over 1 hour (pre exercise to post exercise)
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Validation of 24 hour dietary recall against observed intake
기간: Over 48 hours
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Direct comparison between observed and reported food intake (kJ, % energy contribution from macronutrients)
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Over 48 hours
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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. .
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