Physical Inactivity and Appetite Regulation
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 40
- Male
- Age ≥ 40 years and ≤ 55 years
- Body mass index (BMI) > 20 and < 25 kg/m2
- 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.
- Healthy (based on self-reporting, pre-study medical examination and biochemical screening)
- Can adhere to two weeks of inactivity (refrain from running, cycling and all other exercise while reducing steps to max. 1500 pr. day)
- Caucasian
- No change in body weight > 5 kg within the last 6 months
- Eats breakfast and lunch daily
- Does not follow specific dietary restrictions
- No disliking of spaghetti bolognese
- No diagnosis of psychiatric disorder or treatment with anti-depressant or anti-psychotic medication
- No history of suicidal behavior or ideations.
- No previous surgical treatment for obesity
- No cardiovascular disease
- No rheumatologic disease
- No metabolic/endocrine disease
- No liver disease (ASAT or ALAT >2x upper normal range)
- No other chronic disease
- No elite sports
- No frequent or chronic use of medications affecting bodyweight, physical performance, or inflammation (NSAIDS, DMARDS, corticosteroids)
- No current infection
- No history of cancer
- No anemia (hematocrit <33%)
- No smoking
- No participation in other research intervention studies
- Clinical or biochemical signs of disease
- HbA1c > 39 mmol/mol
- Unable to allocate the needed time to fulfill the intervention
- 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
Copenhagen University Hospital🇩🇰Copenhagen, DenmarkGrit E LegårdContact+45 35457641grit.elster.legaard@regionh.dk