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

Study Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-02-02
• Study Start: 2024-03-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-06
• Study Completion: 2026-06

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

Name	Time	Method
The change in food intake at an ad libitum meal during GLP-1 infusion	From baseline (week 0) to follow-up (week 2).	Food intake will be evaluated as ingested food in grams

Secondary Outcome Measures

Name	Time	Method
The change in subjective experience of severity and type of food cravings	From baseline (week 0) to follow-up (week 2)	Evaluated by the Control of Eating Questionnaire.
The change in subjective feeling of satiety	From baseline (week 0) to follow-up (week 2)	Evaluated by a visual analogue scale
The change in subjective felling of hunger	From baseline (week 0) to follow-up (week 2)	Evaluated by a visual analogue scale
The change in satiety composite appetite score	From 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