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Determinants of Post-Exercise Eating Patterns (DEEP)

2019年7月23日 更新者:Aaron Sim、Clinical Nutrition Research Centre, Singapore

Determinants of Post-Exercise Eating Patterns / Alternative Title (Cover): Effect of Pre-meal Activities on Blood Pressure in Healthy Adults

This study examines potential physiological and psychological determinants of food intake in response to exercise. Specifically, beyond measuring actual food consumption and physiological markers typically assessed during exercise and appetite work (i.e. appetite hormones, blood glucose), the investigators wish to investigate the influence of individual behavioural differences (attitudes towards eating, licensing/compensatory health beliefs, self-regulation, and exercise-associated motivation) on the relationship between exercise and eating behaviour.

研究概览

研究类型

介入性

注册 (预期的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Male
  • Inactive (< 90 min of moderate-intensity exercise a week)
  • BMI: 23 and above
  • Age between 21 to 40 years
  • Normal fasting blood glucose levels equal to or less than 5.9 mmol/L
  • Non-smoker
  • No know allergies or intolerance to food
  • Not on any prescribed medication
  • No physical disabilities and/or restrictions; not averse to exercising on a stationary bike or treadmill running
  • No aversion to blood sampling procedures (e.g. finger prick, cannulation)

Exclusion Criteria:

  • Female,
  • Smoker,
  • Fasting blood glucose > 5.9 mmol/L,
  • Resting blood pressure > 140/90 mmHg,
  • Any major medical/health conditions including

    • Diabetes,
    • Metabolic disease
    • Hypertension,
    • Cardiovascular disease,
    • Thyroid disorders,
    • G6PD deficiency.
  • Allergic or intolerant to foods presented in the study.
  • Physical disabilities and/or restrictions.
  • Individuals that are adverse to exercising on a stationary exercise bike or treadmill.
  • Adverse to blood sampling procedures (i.e. cannulation, finger pricks, venepuncture).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Exercise and Meal (EX)
The EX protocol will involve a 30 minute acute bout of high intensity intermittent exercise on a stationary exercise bike followed by an ad-libitum test meal.
30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal
实验性的:No-Exercise and Meal (NEX)
The NEX protocol will involve a 30 minute period of rest (to match the exercise period in EX) where participants will be provided a video/movie. Following this, participants will be provided ad-libitum access to a test meal (as per EX energy intake assessment protocol)
30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).
大体时间:3 hours
Participants' eating behaviour will be assessed by measuring the total amount of the test meal consumed in each experimental condition. The test meal will be provided ad-libitum (i.e. there will be non-restricted access)
3 hours

次要结果测量

结果测量
措施说明
大体时间
Appetite-related blood hormone concentration in response to experimental conditions.
大体时间:3 hours
Venous blood will be sampled for the measurement of a range of appetite-related hormones including Active Ghrelin (pg/ml), Glucagon-like Peptide-1 (GLP-1) (pg/ml), Pancreatic YY (PYY) (pg/ml), Pancreatic Polypeptide (PP) (pg/ml), periodically through the experimental sessions.
3 hours
Metabolic blood variable concentration in response to experimental conditions
大体时间:3 hours
Venous blood will be sampled for the measurement of metabolic blood variables blood insulin (mmol/L) and blood glucose (mmol/L) periodically through the experimental sessions.
3 hours
Subjective ratings of hunger in response to experimental conditions
大体时间:3 hours
Self-reported subjective ratings of hunger will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales.
3 hours
Subjective ratings of satiation (fullness) in response to experimental conditions
大体时间:3 hours
Self-reported subjective ratings of satiation (fullness) will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales
3 hours
Subjective ratings of desire to eat in response to experimental conditions
大体时间:3 hours
Self-reported subjective ratings of desire to eat will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales
3 hours
Subjective ratings of prospective food consumption in response to experimental conditions
大体时间:3 hours
Self-reported subjective ratings of prospective food consumption will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales.
3 hours
Free-living energy intake (1 day post-experiment) in response to experimental conditions
大体时间:1 day
1 day free-living energy intake (self-report)
1 day
Free-living physical activity levels intake (1 day post-experiment) in response to experimental conditions
大体时间:1 day
1 day free-living physical activity levels (physical activity monitors)
1 day

其他结果措施

结果测量
措施说明
大体时间
Self-reported tendencies of compensatory health beliefs
大体时间:Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported tendencies of compensatory health beliefs on the relationship between experimental conditions and study outcomes. Scale to be used:

Compensatory Health Belief (CHB) Scale, CHB Subscales: Substance use, Eating/sleeping habits, Stress and Weight regulation, Ratings on a 5-point agreement scale. Greater scores (summed) indicate greater tendency for an individual to hold compensatory beliefs (for the particular domain/subscale or collectively).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported tendencies of licensing/reward beliefs
大体时间:Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported tendencies of licensing eating behaviour in response to exercise on the relationship between experimental conditions and study outcomes. Scale to be used:

Post-Exercise Licensing (PEL)Scale. Ratings on a 7 point agreement scale. Greater scores (averaged) indicate a greater tendency to reward/license in response to exercise.

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported tendencies and motives of compensatory eating behaviour in response to exercise
大体时间:Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported tendencies and motives of compensatory eating behaviour in response to exercise on the relationship between experimental conditions and study outcomes Scale to be used:

Compensatory Eating Motives Questionnaire (CEMQ) Subscales: Eating for Reward, Eating for Recovery, Eating for Relief (4 point frequency scale) Greater scores (summation of outcome of respective subscales) indicate greater tendency to compensate due to particular motive (respective subscales).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported assessment of motivation (regulation) to exercise
大体时间:Assessed at start of study - through study completion - up to 4-5 weeks

To examine the influence of self-reported motivation to exercise on the relationship between experimental conditions and study outcomes. Scale involve:

Behavioural Regulation in Exercise Questionnaire (BREQ) measures the stages of the self-determination contin. Subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation.Greater scores (averaged of outcome of respective subscale/items) indicate greater tendency for exercise behaviour to be regulated by particular construct (respective subscale).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported assessment of motivation to eat healthily
大体时间:Assessed at start of study - through study completion - up to 4-5 weeks

To examine the influence of self-reported motivation to adopt healthy eating behaviour on the relationship between experimental conditions and study outcomes. Scale involve:

Regulation of Eating Behavioural Scale (REBS). Subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation. Greater scores (averaged of outcome of respective subscale/items) indicate greater tendency for eating behaviour to be regulated by particular construct (respective subscale).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported attitudes towards eating behaviour as assessed by the Three Factor Eating Behaviour Questionnaire (TFEQ-R18)
大体时间:Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported attitudes towards eating on the relationship between experimental conditions and study outcomes. Scale involve:

Three Factor Eating Behaviour Questionnaire (TFEQ-R18) Subscales: Dietary Restraint, Uncontrolled Eating, Emotional Eating Greater scores (averaged outcome of respective subscale/items) indicate greater likelihood of the behaviour (of construct measure by respective subscales).

Assessed at start of study - through study completion - up to 4-5 weeks
Self-reported weight-related behaviour change status as assessed by the Physical Activity Stages of Change Questionnaire
大体时间:Assessed at start of study - through study completion - up to 4-5 weeks

Influence of self-reported weight-related behaviour change status on the relationship between experimental conditions and study outcomes. Scale involve:

Physical Activity Stages of Change Questionnaire. Scores (based on scoring algorithm) will indicate participants' current stage of motivational readiness for change specific to physical activity. Greater score (1-5 representing five stages of change) indicates physical activity status and intent to be active.

Assessed at start of study - through study completion - up to 4-5 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年9月27日

初级完成 (预期的)

2019年9月1日

研究完成 (预期的)

2019年9月1日

研究注册日期

首次提交

2018年8月7日

首先提交符合 QC 标准的

2018年8月21日

首次发布 (实际的)

2018年8月22日

研究记录更新

最后更新发布 (实际的)

2019年7月25日

上次提交的符合 QC 标准的更新

2019年7月23日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2017/01034

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)

Will be made available to other researchers upon request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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Exercise and Meal (EX)的临床试验

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