NCT06895837

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
25mo left

Started Jul 2025

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jul 2025Apr 2028

First Submitted

Initial submission to the registry

March 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

March 19, 2025

Last Update Submit

January 4, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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

    At 24 hours

  • Macro-nutrient Intake

    At 24 hours

Study Arms (3)

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.

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.

Other: Severe-energy restriction with exercise

Interventions

The participants will receive only 25% of their estimated energy needs.

Severe-energy restriction

The participants will run on the treadmill for 30 minutes and receive 25% of their estimated energy needs.

Severe-energy restriction with exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males aged 18 years or older.
  • Have stable body mass for at least six months (within ±2 kg).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Lister Building, Glasgow Royal Infirmary

Glasgow, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 10702749BACKGROUND
  • 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.

    PMID: 27999089BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • James Dorling, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Human Nutrition (Medicine)

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 26, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Data will be preserved for 10 years.

Locations