Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT06240208
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT06240208
Study Brief:
Protocol Section:
NCT06240208