Overweight
Conditions
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
To contextualize the changes in ad libitum food intake driven by two weeks of physical inactivity, a sub-study will assess the effect of GLP-1 infusion on ad libitum food intake compared with a saline control in 20 participants included based on same eligibility criteria as in the main study. The estimated GLP-1 induced change in ad libitum food intake will be descriptively compared to the estimated GLP-1 + inactivity induced change in ad libitum food intake (main-study) to provide context for any attenuation in appetite suppression observed in the main-study. Outcomes related to subjective appetite measures (hunger, satiety, and food preference) will also be assessed in this way. The primary hypothesis is that GLP-1 infusion will suppress appetite and reduce ad libitum food intake compared with saline control. The secondary hypothesis is that GLP-1 infusion will diminish subjective feelings of hunger and increase satiety.
Interventions
BEHAVIORALInactivity
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.
Sponsors
Rigshospitalet, Denmark
Novo Nordisk A/S
TrygFonden, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Sub study | Sub study | Comparison between Ad libitum meal +/- GLP-1 infusion on primary and secondary outcomes of the primary study. |
Countries
Denmark
Contacts
CONTACTInge Holm
CONTACTBente K Pedersen, Dr Med
PRINCIPAL_INVESTIGATORGrit Elster Legård, MD, PhD
Centre for Physical Activity Research, Rigshospitalet
Outcome results
None listed