- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06895837
Effect of Exercise on Appetite in Response to Meals During Energy Restriction
Acute Effect of Exercise on Appetite, Appetite-Regulatory Hormones, and Energy Intake During Energy Restriction in Healthy Men
This study's primary aim is to investigate the acute effect of an exercise bout (30 minutes) on appetite and appetite-regulatory hormone responses during energy restriction. The researchers will also test if the exercise bout influences ad libitum energy intake after a period of energy restriction.
The researchers will compare three groups (control, severe-energy restriction, and severe-energy restriction with exercise) to see if exercise bout, during energy restriction, affects appetite, appetite-regulatory hormones, and energy intake in healthy men.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Before the main experiments are conducted, participants will attend a screening visit where the participants will provide consent and complete questionnaires that assess their health, food preferences, and physical activity levels. Researchers will then measure the participants' height, weight, waist circumference, and body composition.
Once the eligibility criteria are confirmed, participants will participate in two treadmill tests to establish their maximum oxygen uptake (V̇O2 max).
After the screening visit, participants will participate in three main experiments, each lasting 24 hours: control, severe energy restriction, and severe energy restriction with exercise. These experiments will be conducted in a counterbalanced design. Each experiment will start around 9:30 AM, following an overnight fast of at least 10 hours. Participants will have a prescribed meal in the evening before each main experiment. After this meal, the participants are only allowed to drink water until the start of the main experiments.
During the exercise trial, participants will begin by running on a treadmill for 30 minutes at a speed estimated to achieve 75% of their V̇O2 peak, followed by a rest period in the laboratory. The same protocol will be followed in the control and severe-energy trials, except that no exercise will be performed. Participants will rest in the laboratory during both the control and energy-restricted trials. In the control trial, the participants will receive 100% of their estimated energy needs; in the energy-restricted trials, the participants will receive only 25%.
The participants will have standardized breakfast and lunch meals at 1h and 5h, respectively. At 24h, participants will be provided an ad libitum buffet meal in a private eating room.
The researchers will assess appetite ratings in each experiment using 100 mm visual analog scales. The researchers will also collect blood samples to analyze ghrelin, peptide YY (PYY), glucagon-like peptide 1 (GLP-1), and potentially other blood-borne measures.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sultan Alenezi, MSc
- Phone Number: +44 778 653 0734
- Email: a.sultan-kheneisr-w.1@research.gla.ac.uk
Study Contact Backup
- Name: James Dorling, PhD
- Phone Number: +44 141 201 6696
- Email: James.Dorling@glasgow.ac.uk
Study Locations
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-
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Glasgow, United Kingdom
- Recruiting
- New Lister Building, Glasgow Royal Infirmary
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Contact:
- Sultan Alenezi
- Phone Number: +447786530734
- Email: a.sultan-kheneisr-w.1@research.gla.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males aged 18 years or older.
- Have stable body mass for at least six months (within ±2 kg).
Exclusion Criteria:
- Females
- People who are younger than 18 or older than 65 years old.
- Following a special diet (e.g. weight loss, vegetarian or vegan, etc.).
- Have food allergies related to the study.
- Have significant contraindications to exercise (e.g., an injury that would inhibit running).
- Smoking.
- Taking any medications.
- Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.
- Have any mental health conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
The participants will not perform any exercise and will receive 100% of their estimated energy needs.
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|
|
Experimental: Severe-energy restriction
The participants will not perform any exercise and will receive 25% of their estimated energy needs.
|
The participants will receive only 25% of their estimated energy needs.
|
|
Experimental: Severe-energy restriction with exercise
The participants will run on the treadmill for 30 minutes and receive 25% of their estimated energy needs.
|
The participants will run on the treadmill for 30 minutes and receive 25% of their estimated energy needs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Peptide-YY (PYY)
Time Frame: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
|
The researchers will draw blood samples at different time points during the trial to measure the change in PYY blood levels.
Area under the plasma concentration versus time curve (AUC) of PYY will be calculated using the trapezoidal rule.
|
At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
|
|
Change in Ghrelin
Time Frame: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
|
The researchers will draw blood samples at different time points during the trial to measure the change in ghrelin blood levels.
Area under the plasma concentration versus time curve (AUC) of ghrelin will be calculated using the trapezoidal rule.
|
At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
|
|
Change in Glucagon-Like Peptide-1 (GLP-1)
Time Frame: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
|
The researchers will draw blood samples at different time points during the trial to measure the change in GLP-1 blood levels.
Area under the plasma concentration versus time curve (AUC) of GLP-1 will be calculated using the trapezoidal rule.
|
At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
|
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Change in subjective appetite sensations
Time Frame: At 0 (baseline), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 23, 24, and 25 hours
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The researchers will assess the subjective appetite sensations using 100 mm visual analog scales (VAS) to measure appetite sensations (hunger, satiety, fullness, prospective food consumption, and desire to eat).
The VAS are 100 mm long, with words anchored at each end expressing the most positive and negative ratings.
Scores for each appetite construct range from 0-100.
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At 0 (baseline), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 23, 24, and 25 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy Intake
Time Frame: At 24 hours
|
To determine the amount of each food item consumed, the researchers will measure the difference in weight between before and after the meal.
The researchers will use manufacturer details to determine energy consumption.
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At 24 hours
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Macro-nutrient Intake
Time Frame: At 24 hours
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To determine the amount of each food item consumed, the researchers will measure the difference in weight between before and after the meal.
The researchers will use manufacturer details to determine macro-nutrient consumption.
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At 24 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Dorling, PhD, University of Glasgow
Publications and helpful links
General Publications
- Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
- Broom DR, Miyashita M, Wasse LK, Pulsford R, King JA, Thackray AE, Stensel DJ. Acute effect of exercise intensity and duration on acylated ghrelin and hunger in men. J Endocrinol. 2017 Mar;232(3):411-422. doi: 10.1530/JOE-16-0561. Epub 2016 Dec 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200240250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The stored data will be pseudonymous and follow the guidelines of the General Data Protection Regulation enforced in May 2018. Hard copies of participant information forms, including consent forms and dietary intake records, will be kept in locked filing cabinets. Keys to the filing cabinets will only be available to the primary investigator. All databases will be password protected and stored on a university computer with firewalls.
Participants' identifiable data will be stored in a locked cabinet. Digital data will be stored anonymously within the server of the University of Glasgow.
This project's Principal Investigator will be responsible for sharing the research data.
Data will be preserved in Enlighten, the official online repository of Glasgow University's research output.
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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