Determinants of Post-Exercise Eating Patterns

Obesity Clinical Trial

— DEEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03643315
• Other study ID #: 2017/01034
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: September 2019

Study information

• Verified date: July 2019
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: Aaron Y Sim, PhD
• Phone: +6564074046
• Email: aaron_sim[@]sics.a-star.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Exercise and Meal (EX)
30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal
• No-Exercise and Meal (NEX)
30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore	Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported tendencies of compensatory health beliefs	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
Other	Self-reported tendencies of licensing/reward beliefs	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
Other	Self-reported tendencies and motives of compensatory eating behaviour in response to exercise	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
Other	Self-reported assessment of motivation (regulation) to exercise	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
Other	Self-reported assessment of motivation to eat healthily	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
Other	Self-reported attitudes towards eating behaviour as assessed by the Three Factor Eating Behaviour Questionnaire (TFEQ-R18)	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
Other	Self-reported weight-related behaviour change status as assessed by the Physical Activity Stages of Change Questionnaire	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
Primary	Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).	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
Secondary	Appetite-related blood hormone concentration in response to experimental conditions.	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
Secondary	Metabolic blood variable concentration in response to experimental conditions	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
Secondary	Subjective ratings of hunger in response to experimental conditions	Self-reported subjective ratings of hunger will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales.	3 hours
Secondary	Subjective ratings of satiation (fullness) in response to experimental conditions	Self-reported subjective ratings of satiation (fullness) will be assessed periodically through the experimental session. Assessed via 100-point visual analogue scales	3 hours
Secondary	Subjective ratings of desire to eat in response to experimental conditions	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
Secondary	Subjective ratings of prospective food consumption in response to experimental conditions	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
Secondary	Free-living energy intake (1 day post-experiment) in response to experimental conditions	1 day free-living energy intake (self-report)	1 day
Secondary	Free-living physical activity levels intake (1 day post-experiment) in response to experimental conditions	1 day free-living physical activity levels (physical activity monitors)	1 day