Clinical trial NCT06895837: Effect of Exercise on Appetite in Response to Meals During Energy Restriction
Official title: Acute Effect of Exercise on Appetite, Appetite-Regulatory Hormones, and Energy Intake During Energy Restriction in Healthy Men
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Peptide-YY (PYY)
timeFrame: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
measure: Change in Ghrelin
timeFrame: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
measure: Change in Glucagon-Like Peptide-1 (GLP-1)
timeFrame: At 0 (baseline), 0.5, 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 23 hours
measure: Change in subjective appetite sensations
timeFrame: 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:
measure: Energy Intake
timeFrame: At 24 hours
measure: Macro-nutrient Intake
timeFrame: At 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Glasgow
name: James Dorling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.