NCT06296511

Brief Summary

A key area of obesity research has focused on the link between appetite, energy balance and weight control. Within this area, several appetite-related hormones and cellular cytokines have been identified as key signals influencing appetite and food intake. This includes the appetite-suppressing hormone oxyntomodulin (OXM) and a cellular stress-induced cytokine growth differentiation factor 15 (GDF-15). The aims of this study are: (1) to investigate the effect of acute moderate-intensity continuous exercise on oxyntomodulin and GDF-15 concentrations; (2) to investigate whether exercise-induced changes in circulating OXM and GDF-15 concentrations are correlated with subjective appetite perceptions and subsequent energy intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable obesity

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

June 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
Last Updated

March 6, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 29, 2024

Last Update Submit

February 29, 2024

Conditions

Keywords

ExerciseAppetiteOxyntomodulinGrowth differentiation factor 15GDF-15

Outcome Measures

Primary Outcomes (2)

  • Oxyntomodulin

    (pmol/L)

    Blood samples were collected for oxyntomodulin measurements at 0 (baseline), 60, 90, 120, 150, 180, 210 minutes in each trial.

  • Growth Differentiation Factor 15

    (pg/mL)

    Blood samples were collected for GDF-15 measurements at 0 (baseline), 60, 90, 120, 150, 180, 210 minutes in each trial.

Secondary Outcomes (2)

  • Visual analogue score (VAS) for subjective appetite

    VAS was measured at 0 (baseline), 60, 90, 120, 150, 180, 210 minutes in each trial.

  • Energy intake

    Ad libitum pasta meal provided at 120 minutes.

Study Arms (2)

Exercise

EXPERIMENTAL

Participants were asked to arrive at the lab at 8.30 am, having fasted overnight for 10 hours. After resting in the lab for 30 minutes, participants were asked to exercise at an intensity of 70 percent of their peak oxygen uptake for an hour before resting in the lab for a further 2.5 hours. Ad libitum energy intake was assessed 1 h after exercise completion.

Behavioral: Exercise

Control

NO INTERVENTION

Participants replicated all the procedures of the exercise trial except they rested for 1 h as the exercise counterpart.

Interventions

ExerciseBEHAVIORAL

60 min of treadmill exercise performed at 70% of peak oxygen uptake.

Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index between 18.5-24.9 kg/m²;
  • Habitually consume three meals a day;
  • Able to run continuously for 1 hour;
  • Not currently dieting and weight stable for 3 months (\< 3 kg change in weight);
  • No severe dislike or allergy to any of the study food;
  • Regular menstrual cycle in the past 6 months.

You may not qualify if:

  • Smokers (vaping is considered smoking in this study);
  • Individuals with medical conditions (e.g., diabetes, heart condition);
  • Individuals taking medications that may influence the study outcomes;
  • Individuals with clinically diagnosed eating disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 6, 2024

Study Start

June 23, 2023

Primary Completion

November 7, 2023

Study Completion

November 7, 2023

Last Updated

March 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Anonymised data will be made available to researchers upon request.

Locations