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Physical Inactivity and Appetite Regulation 40 Exercise-Based

Recruiting
Clinical Trial NCT06240208 is an interventional study for Overweight that is recruiting. It started on March 1, 2024 with plans to enroll 40 participants. Led by Rigshospitalet, Denmark, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary

The goal of this parallel-group, two-arm, assessor-blinded, randomised clinical trial is to investigate the effects of reducing physical activity on food intake and satiety in physically active and healthy males, 40-55 years of age.

The main questions it aims to answer are:

  • Does physical inactivity affect GLP-1 stimulated food intake?
  • Does physical inactivity affect food preferences, satiety and other mechanism...
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Detailed Description
To contextualize the changes in ad libitum food intake driven by two weeks of physical inactivity, a sub-study will assess the effect of GLP-1 infusion on ad libitum food intake compared with a saline control in 20 participants included based on same eligibility criteria as in the main study. The estimated GLP-1 induced change in ad libitum food intake will be descriptively compared to the estimated GLP-1 + inactivit...Show More
Official Title

The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study

Conditions
Overweight
Other Study IDs
  • H-23055497
NCT ID Number
NCT06240208
Start Date (Actual)
2024-03-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalInactivity
Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day.
Inactivity
Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day.
No InterventionControl
Participants will be instructed to maintain habitual physical activity and dietary habits.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The change in food intake at an ad libitum meal during GLP-1 infusion
Food intake will be evaluated as ingested food in grams
From baseline (week 0) to follow-up (week 2).
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The change in preference for unhealthy food ( combined score for high fat food, savory food, and sweet food).
Evaluated by visual food stimuli combined with eye tracking
From baseline (week 0) to follow-up (week 2)
The change in subjective experience of severity and type of food cravings
Evaluated by the Control of Eating Questionnaire.
From baseline (week 0) to follow-up (week 2)
The change in subjective feeling of satiety
Evaluated by a visual analogue scale
From baseline (week 0) to follow-up (week 2)
The change in subjective felling of hunger
Evaluated by a visual analogue scale
From baseline (week 0) to follow-up (week 2)
The change in satiety composite appetite score
Calculated from visual analog scales
From baseline (week 0) to follow-up (week 2)
Sub study
Comparison between Ad libitum meal +/- GLP-1 infusion on primary and secondary outcomes of the primary study.
Sub study
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
40 Years
Eligible Sexes
Male
Accepts Healthy Volunteers
Yes
  1. Male
  2. Age ≥ 40 years and ≤ 55 years
  3. Body mass index (BMI) > 20 and < 25 kg/m2
  4. Physical activity level should as a minimum include: Active commuting by biking a minimum of 10 km, four days per week or an equivalent amount of other physical activity four days per week.
  5. Healthy (based on self-reporting, pre-study medical examination and biochemical screening)
  6. Can adhere to two weeks of inactivity (refrain from running, cycling and all other exercise while reducing steps to max. 1500 pr. day)
  7. Caucasian
  8. No change in body weight > 5 kg within the last 6 months
  9. Eats breakfast and lunch daily
  10. Does not follow specific dietary restrictions
  11. No disliking of spaghetti bolognese
  12. No diagnosis of psychiatric disorder or treatment with anti-depressant or anti-psychotic medication
  13. No history of suicidal behavior or ideations.
  14. No previous surgical treatment for obesity
  15. No cardiovascular disease
  16. No rheumatologic disease
  17. No metabolic/endocrine disease
  18. No liver disease (ASAT or ALAT >2x upper normal range)
  19. No other chronic disease
  20. No elite sports
  21. No frequent or chronic use of medications affecting bodyweight, physical performance, or inflammation (NSAIDS, DMARDS, corticosteroids)
  22. No current infection
  23. No history of cancer
  24. No anemia (hematocrit <33%)
  25. No smoking
  26. No participation in other research intervention studies

  1. Clinical or biochemical signs of disease
  2. HbA1c > 39 mmol/mol
  3. Unable to allocate the needed time to fulfill the intervention
  4. Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions
Rigshospitalet, Denmark logoRigshospitalet, Denmark
Study Responsible Party
Grit Elster Legård, Principal Investigator, Primary Investigator, Rigshospitalet, Denmark
Study Central Contact
Contact: Inge Holm, +45 35 45 76 41, [email protected]
Contact: Bente K Pedersen, Dr Med, +45 35 45 76 41, [email protected]
1 Study Locations in 1 Countries
Copenhagen University Hospital, Copenhagen, Denmark
Grit E Legård, Contact, +45 35457641, [email protected]
Recruiting