MedPath

Physical Inactivity and Appetite Regulation

Not Applicable
Recruiting
Conditions
Overweight
Registration Number
NCT06240208
Lead Sponsor
Rigshospitalet, Denmark
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 mechanisms supporting appetite regulation?

Participants will be randomised (1:1) to two weeks of either no intervention (control group) or 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.

Researchers will compare the inactivity group to the control group to see if physical inactivity impairs appetite regulation.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Male
Target Recruitment
40
Inclusion Criteria
  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
Exclusion Criteria
  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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The change in food intake at an ad libitum meal during GLP-1 infusionFrom baseline (week 0) to follow-up (week 2).

Food intake will be evaluated as ingested food in grams

Secondary Outcome Measures
NameTimeMethod
The change in subjective experience of severity and type of food cravingsFrom baseline (week 0) to follow-up (week 2)

Evaluated by the Control of Eating Questionnaire.

The change in subjective feeling of satietyFrom baseline (week 0) to follow-up (week 2)

Evaluated by a visual analogue scale

The change in subjective felling of hungerFrom baseline (week 0) to follow-up (week 2)

Evaluated by a visual analogue scale

The change in satiety composite appetite scoreFrom baseline (week 0) to follow-up (week 2)

Calculated from visual analog scales

The change in preference for unhealthy food ( combined score for high fat food, savory food, and sweet food).From baseline (week 0) to follow-up (week 2)

Evaluated by visual food stimuli combined with eye tracking

Trial Locations

Locations (1)

Copenhagen University Hospital

🇩🇰

Copenhagen, Denmark

Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Grit E Legård
Contact
+45 35457641
grit.elster.legaard@regionh.dk

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.