HealthyNCT06895837
Effect of Exercise on Appetite in Response to Meals During Energy Restriction
A study testing Severe-energy restriction and Severe-energy restriction with exercise in people with Healthy, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Severe-energy restriction and Severe-energy restriction with exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males aged 18 years or older.
- Have stable body mass for at least six months (within ±2 kg).
Who cannot join
- 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.
Show all 9Show fewer
- Taking any medications.
- Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.
- Have any mental health conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
New Lister Building, Glasgow Royal Infirmary
Glasgow
Sultan Alenezi, +447786530734, a.sultan-kheneisr-w.1@research.gla.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Severe-energy restriction, Severe-energy restriction with exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe-energy restrictionOther
The participants will receive only 25% of their estimated energy needs.
Severe-energy restriction with exerciseOther
The participants will run on the treadmill for 30 minutes and receive 25% of their estimated energy needs.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The participants will not perform any exercise and will receive 100% of their estimated energy needs. |
| Severe-energy restriction | Experimental | The participants will not perform any exercise and will receive 25% of their estimated energy needs. Receives: Other: Severe-energy restriction |
| Severe-energy restriction with exercise | Experimental | The participants will run on the treadmill for 30 minutes and receive 25% of their estimated energy needs. Receives: Other: Severe-energy restriction with exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peptide-YY (PYY)
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.
Measured: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
Change in Ghrelin
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.
Measured: 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)
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.
Measured: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
Change in subjective appetite sensations
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.
Measured: 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 outcomes (2)
Energy Intake
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.
Measured: At 24 hours
Macro-nutrient Intake
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.
Measured: At 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start30 Jul 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Border University
- Responsible party
- Principal investigator, James Dorling, PhD, University of Glasgow
- Investigators
- James Dorling, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895837
- Sponsor's protocol ID
- 200240250
- Status last verified
- Jan 2026
- First submitted
- 19 Mar 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 10702749Broom 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.
PubMed 27999089
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Exercise on Appetite, Appetite-Regulatory Hormones, and Energy Intake During Energy Restriction in Healthy Men
- ClinicalTrials.gov ID
- NCT06895837
- Acronym / sponsor ID
- 200240250
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Northern Border University
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The participants will not perform any exercise and will receive 100% of their estimated energy needs. |
| Severe-energy restriction | Experimental | Other: Severe-energy restrictionThe participants will not perform any exercise and will receive 25% of their estimated energy needs. |
| Severe-energy restriction with exercise | Experimental | Other: Severe-energy restriction with exerciseThe participants will run on the treadmill for 30 minutes and receive 25% of their estimated energy needs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males aged 18 years or older.
- Have stable body mass for at least six months (within ±2 kg).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Severe-energy restrictionThe participants will receive only 25% of their estimated energy needs. | Other | Severe-energy restriction |
| Severe-energy restriction with exerciseThe participants will run on the treadmill for 30 minutes and receive 25% of their estimated energy needs. | Other | Severe-energy restriction with exercise |
Primary outcome
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.
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.
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.
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
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.
2 secondary outcomes
Energy Intake
Time frame: At 24 hours
Macro-nutrient Intake
Time frame: At 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 10702749Flint 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.
- Background: PubMed 27999089Broom 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Dorling, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Severe-energy restriction and Severe-energy restriction with exercise in people with Healthy, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sultan Alenezi, MSc (+44 778 653 0734, a.sultan-kheneisr-w.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06895837, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.