Physical Inactivity and Appetite Regulation

Last updated: November 13, 2024
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypertriglyceridemia

Obesity

Treatment

Inactivity

Clinical Study ID

NCT06240208
H-23055497
  • Ages 40-55
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 aminimum of 10 km, four days per week or an equivalent amount of other physicalactivity four days per week.

  5. Healthy (based on self-reporting, pre-study medical examination and biochemicalscreening)

  6. Can adhere to two weeks of inactivity (refrain from running, cycling and all otherexercise 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 oranti-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, physicalperformance, 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

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 andbe able to complete the interventions

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Inactivity
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Copenhagen University Hospital

    Copenhagen,
    Denmark

    Active - Recruiting

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