NCT06849050

Brief Summary

Exercise increases energy expenditure and impacts appetite and energy intake. Some appetite-related hormones such as oxyntomodulin suppress appetite whilst other hormones such as ghrelin stimulate appetite. This study will investigate whether acute continuous walking/jogging influences these hormone concentrations, and whether exercise-induced changes in the hormones correlate with perceptions of appetite, nutritional intake and brain activity in individuals varying in weight status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2025

Completed
Last Updated

September 10, 2025

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

February 18, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

AppetiteObesityOverweightfMRINeural correlatesExerciseOxyntomodulin

Outcome Measures

Primary Outcomes (1)

  • Concentration of Oxyntomodulin

    Plasma blood samples

    Blood samples to measure oxyntomodulin are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.

Secondary Outcomes (11)

  • Concentration of Acylated Ghrelin

    Blood samples to measure acylated ghrelin are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.

  • Concentration of Leptin

    Blood samples to measure leptin are collected at 0 hours [08:30] in each trial.

  • Concentration of Glucagon-like peptide 1

    Blood samples to measure GLP-1 are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.

  • Concentration of Peptide YY

    Blood samples to measure PYY are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.

  • Concentration of Glucose

    Blood samples to measure glucose are collected at 30-minute intervals (0 hours [08:30], 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours and 4 hours) in each trial.

  • +6 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Rest in the laboratory from 08:00 to 13:00. For 30-minutes, participants will be asked to wear a face mask, which will measure their oxygen consumption at rest. Ad libitum energy intake assessed at 11:00 (2.5 hours).

Exercise

EXPERIMENTAL

Rest in the laboratory from 08:00 to 13:00 apart from 60 minutes of treadmill exercise (walking/jogging) performed between 09:00-10:00 (0.5-1.5 hours). Ad libitum energy intake assessed at 11:00 (2.5 hours).

Behavioral: Acute continuous exercise

Interventions

Exercise, which will involve 60 minutes of brisk walking, or jogging, at 60% of peak oxygen uptake. Participants will be asked to wear a face mask, which will measure their oxygen consumption during the exercise session.

Exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) between 18.5 - 24.9 kg/m2 and a waist circumference of ≤ 88 cm for women, and ≤ 102 cm for men or a BMI between 25 - 40 kg/m2 and a waist circumference of \> 88 cm for women, and \> 102 cm for men. BMI and waist circumference thresholds vary amongst ethnicities. People with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family background are prone to central adiposity and their cardiometabolic risk occurs at a lower BMI. Therefore, the following BMI and waist circumference thresholds will be applied for people of South Asian, other Asian, Black African and African-Caribbean ethnicity: (1) BMI 18.5 kg/m2 to 23 kg/m2 and waist circumference of \< 90 cm for men and \< 80 cm for women; (2) BMI 23.1 kg/m2 to 40 kg/m2 and waist circumference of ≥ 90 cm for men and ≥ 80 cm for women.
  • Normally consumes three meals a day
  • Able to walk continuously for 1 hour on a treadmill
  • Weight stable for 3 months (\< 3kg change in weight)
  • Regular menstrual cycle for the last 6 months (people taking the combined contraceptive pill are eligible for the study)
  • Able to undergo a 45-minute MRI scan

You may not qualify if:

  • Smokers (vaping is considered smoking in this study)
  • Known medical conditions (e.g. diabetes, heart condition)
  • Taking any medication which may affect the study outcomes (e.g. liraglutide, semaglutide, insulin, steroids, anti-psychotics)
  • Clinically diagnosed eating disorder
  • Previous bariatric surgery (e.g. gastric bypass, gastric band, sleeve gastrectomy)
  • Food allergies or intolerances, or severe dislikes to study foods
  • Pregnant or breastfeeding
  • Have recently donated blood (within eight weeks of visits 2 and 3).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, United Kingdom

Location

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • David J Stensel

    Loughborough University

    PRINCIPAL INVESTIGATOR

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
Professor of Exercise Metabolism

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 27, 2025

Study Start

July 5, 2024

Primary Completion

September 3, 2025

Study Completion

September 3, 2025

Last Updated

September 10, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Anonymised data will be made available to researchers upon request.

Locations