- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06096233
Effect of Exercise on Appetite in Response to Meals
Acute Effect of Exercise on Post-meal Appetite, Appetite-Regulatory Hormones, and Energy Intake in Healthy Men
Study Overview
Detailed Description
Study Design
Screening visit Before conducting the main experiments, the participants will attend a screening visit where consent will be obtained, and they will complete questionnaires to assess health, food preferences, and physical activity. The researchers will then measure the participants' height, weight, waist circumference, and body composition.
After the researchers confirm the eligibility criteria, participants will take part in two treadmill tests to establish maximum oxygen uptake test (V̇O2 max) (Broom et al. 2017).
Experimental design After the screening visit, the participants will complete three main experiments (control, short high-intensity exercise, and prolonged high-intensity exercise) in a counter-balanced design. All experiments began at ~0930, following an overnight fast of at least 10 hours. Participants will consume a prescribed meal in the evening before each main experiment. Following this meal, participants are only allowed to drink water until the start of the main experiments.
At the beginning of the exercise conditions, participants will run on the treadmill for 10 minutes (short) or 30 minutes (prolonged) at a speed estimated to elicit a 75% V̇O2 peak, followed by rest in the laboratory. In the control condition, the researchers will follow the same protocols except that the participants will not perform any exercise. The participants will have a standardized meal after exercise and then an ad libitum buffet meal afterward.
During each experiment, the researchers will assess appetite ratings using 100 mm visual analog scales (Flint et al. 2000). The researchers will also collect blood samples to examine ghrelin, peptide YY, glucagon-like peptide 1, and possibly 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
-
-
-
Glasgow, United Kingdom, G31 2ER
- Recruiting
- New Lister Building at Glasgow Royal Infirmary
-
Contact:
- Sultan Alenezi, MSc
- Phone Number: +44 778 653 0734
- Email: a.sultan-kheneisr-w.1@research.gla.ac.uk
-
Contact:
- James Dorling, PhD
- Phone Number: +44 141 201 6696
- Email: James.Dorling@glasgow.ac.uk
-
Principal Investigator:
- James Dorling, PhD
-
-
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.
- Have food allergies.
- Have significant contraindications to exercise (e.g., an injury that would inhibit running).
- Smoking.
- Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.
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.
|
|
|
Experimental: Short Exercise
The participants will run on the treadmill for 10 minutes.
|
The participants will run on the treadmill for 10 minutes (short) or 30 minutes (prolonged).
|
|
Experimental: Prolonged Exercise
The participants will run on the treadmill for 30 minutes.
|
The participants will run on the treadmill for 10 minutes (short) or 30 minutes (prolonged).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Peptide-YY (PYY)
Time Frame: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
|
Blood samples will be drawn 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), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
|
|
Change in Ghrelin
Time Frame: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
|
Blood samples will be drawn 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), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
|
|
Change in Glucagon-Like Peptide-1 (GLP-1)
Time Frame: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
|
Blood samples will be drawn 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), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
|
|
Change in subjective appetite sensations
Time Frame: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, and 6 hours
|
The subjective appetite sensations will be assessed 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.
|
At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, and 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy Intake
Time Frame: At 5 hours
|
To determine the amount of each food item consumed, we will measure the difference in weight between before and after the meal.
We will use manufacturer details to determine energy consumption.
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At 5 hours
|
|
Macro-nutrient Intake
Time Frame: At 5 hours
|
To determine the amount of each food item consumed, we will measure the difference in weight between before and after the meal.
We will use manufacturer details to determine macronutrient consumption
|
At 5 hours
|
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
Other Study ID Numbers
- 200220449
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The stored data will be anonymous 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
The data will be available when the study is completed.
Data will be preserved for 10 years.
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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