Clinical trial NCT06096233: Effect of Exercise on Appetite in Response to Meals
Official title: Acute Effect of Exercise on Post-meal Appetite, Appetite-Regulatory Hormones, and Energy Intake in Healthy Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2023-10-23
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 clinical trial's primary aim is to investigate the acute effect of two exercise bouts (short \[10 minutes\] and long \[30 minutes\]) on appetite and appetite-regulatory hormone responses to a standard meal test. The secondary aim is to investigate when the changes in appetite and appetite-regulatory hormones occur during exercise. As an exploratory aim, the researchers will test if the two exercise bouts influence ad libitum energy intake in the periods after the standard meal test. The researchers will compare three groups (control, short exercise, and prolonged exercise) to see if the exercise bouts affect appetite, appetite-regulatory hormones, and energy intake in healthy men.

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.

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.
* 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.

Primary outcomes:
measure: Change in Peptide-YY (PYY)
timeFrame: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
measure: Change in Ghrelin
timeFrame: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
measure: Change in Glucagon-Like Peptide-1 (GLP-1)
timeFrame: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 3, and 4 hours
measure: Change in subjective appetite sensations
timeFrame: At 0 (baseline), 0.167, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, and 6 hours
Secondary outcomes:
measure: Energy Intake
timeFrame: At 5 hours
measure: Macro-nutrient Intake
timeFrame: At 5 hours
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: New Lister Building at Glasgow Royal Infirmary
Study officials:
affiliation: University of Glasgow
name: James Dorling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.