Physical Inactivity and Appetite Regulation
ConditionOverweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-55
SponsorRigshospitalet, Denmark
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Inactivity
BehavioralInactivity 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: InactivityExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The change in food intake at an ad libitum meal during GLP-1 infusion
Food intake will be evaluated as ingested food in grams
Time frame
From baseline (week 0) to follow-up (week 2).Secondary outcomes
1
The change in preference for unhealthy food ( combined score for high fat food, savory food, and sweet food).
Evaluated by visual food stimuli combined with eye tracking
Time frame
From baseline (week 0) to follow-up (week 2)2
The change in subjective experience of severity and type of food cravings
Evaluated by the Control of Eating Questionnaire.
Time frame
From baseline (week 0) to follow-up (week 2)3
The change in subjective feeling of satiety
Evaluated by a visual analogue scale
Time frame
From baseline (week 0) to follow-up (week 2)4
The change in subjective felling of hunger
Evaluated by a visual analogue scale
Time frame
From baseline (week 0) to follow-up (week 2)Other outcomes
1
Change in secretion of gut hormones (GLP-1, GIP, PYY, ghrelin, CCK)
Time frame
From baseline (week 0) to follow-up (week 2)2
Change in gastric emptying rate
Measured by surrogate marker paracetamol
Time frame
From baseline (week 0) to follow-up (week 2)3
Change in body composition (body weight, body mass index, lean mass, fat mass)
Based on DXA scans
Time frame
From baseline (week 0) to follow-up (week 2)4
Change in physical fitness (maximal aerobic capacity, one repetition max)
Time frame
From baseline (week 0) to follow-up (week 2)Sponsors and contacts
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Source ClinicalTrials.gov