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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06096233
Other study ID # 200220449
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 6, 2023
Est. completion date October 5, 2026

Study information

Verified date May 2024
Source University of Glasgow
Contact Sultan Alenezi, MSc
Phone +44 778 653 0734
Email a.sultan-kheneisr-w.1@research.gla.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date October 5, 2026
Est. primary completion date October 5, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Bouts of Exercise
The participants will run on the treadmill for 10 minutes (short) or 30 minutes (prolonged).

Locations

Country Name City State
United Kingdom New Lister Building at Glasgow Royal Infirmary Glasgow

Sponsors (1)

Lead Sponsor Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Peptide-YY (PYY) 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
Primary Change in Ghrelin 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
Primary Change in Glucagon-Like Peptide-1 (GLP-1) 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
Primary Change in subjective appetite sensations 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 Energy Intake 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. At 5 hours
Secondary Macro-nutrient Intake 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
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