Investigating how reduced physical activity affects appetite in healthy men

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

This study is testing how cutting back on physical activity affects appetite and food choices in healthy men aged 40-55.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 40 Years to 55 Years
• Sex: Male
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Locations: 1 site (Copenhagen)
• Trial ID: NCT06240208 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to explore the impact of physical inactivity on food intake and appetite regulation in healthy males aged 40-55. Participants will be randomly assigned to either a control group with no intervention or an inactivity group where they will limit their physical activity to a maximum of 1500 steps per day for two weeks. The study will assess changes in appetite regulation mechanisms, including GLP-1 stimulated food intake and food preferences. The findings could provide insights into how lifestyle changes affect eating behaviors.

Who should consider this trial

Good fit: Ideal candidates are healthy Caucasian males aged 40-55 with a BMI between 20 and 25 who are physically active.

Not a fit: Patients with a history of cardiovascular or rheumatologic diseases, psychiatric disorders, or significant weight changes in the past six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify how reducing physical activity influences appetite regulation, potentially guiding interventions for weight management.

How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated that physical activity levels can significantly influence appetite and food intake.

Eligibility criteria

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

Where this trial is running

Copenhagen

• Copenhagen University Hospital — Copenhagen, Denmark (Recruiting)

Study contacts

• Principal investigator: Grit Elster Legård, MD, PhD — Centre for Physical Activity Research, Rigshospitalet
• Study coordinator: Inge Holm

Conditions Overweight