Copenhagen University Hospital
Copenhagen, Denmark
Location status: Recruiting
NCT Number: NCT06240208
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.
Interested in participating?
Request Info40 year–55 year
Male
Interventional
Not applicable
Copenhagen, Denmark
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From baseline (week 0) to follow-up (week 2).
Food intake will be evaluated as ingested food in grams
Time frame: From baseline (week 0) to follow-up (week 2)
Evaluated by visual food stimuli combined with eye tracking
Time frame: From baseline (week 0) to follow-up (week 2)
Evaluated by the Control of Eating Questionnaire.
Time frame: From baseline (week 0) to follow-up (week 2)
Evaluated by a visual analogue scale
Time frame: From baseline (week 0) to follow-up (week 2)
Evaluated by a visual analogue scale
Time frame: From baseline (week 0) to follow-up (week 2)
Calculated from visual analog scales
Time frame: Sub study
Comparison between Ad libitum meal +/- GLP-1 infusion on primary and secondary outcomes of the primary study.
Time frame: From baseline (week 0) to follow-up (week 2)
Time frame: From baseline (week 0) to follow-up (week 2)
Measured by surrogate marker paracetamol
Time frame: From baseline (week 0) to follow-up (week 2)
Based on DXA scans
Time frame: From baseline (week 0) to follow-up (week 2)
Time frame: From baseline (week 0) to follow-up (week 2)
AUC (mol/hour)
Time frame: From baseline (week 0) to follow-up (week 2)
AUC (mol/h)
Time frame: From baseline (week 0) to follow-up (week 2)
AUC (mol/hour)
Time frame: From baseline (week 0) to follow-up (week 2)
The % glucagon supression at time 0-30min, 0-60min and 0-120min
Time frame: From baseline (week 0) to follow-up (week 2)
Insulin/glucagon at time=30, 60 and 120
Time frame: From baseline (week 0) to follow-up (week 2)
AUC (mol/hour)
Time frame: From baseline (week 0) to follow-up (week 2)
AUC (mol/hour)
Time frame: From baseline (week 0) to follow-up (week 2)
Insulin/glucagon at time 30min, 60min, 120min and 180
Time frame: From baseline (week 0) to follow-up (week 2)
AUC (mol/hour)
Time frame: From baseline (week 0) to follow-up (week 2)
The % glucagon supression at time 0-30min, 0-60min, 0-120min and 0-180
Time frame: From baseline (week 0) to follow-up (week 2)
Insulin/glucagon at time 30min, 60min, 120min and 180
Time frame: From baseline (week 0) to follow-up (week 2)
Time frame: From baseline (week 0) to follow-up (week 2)
Time frame: From baseline (week 0) to follow-up (week 2)
CV% derived from free-living continuous glucose monitoring
Time frame: From baseline (week 0) to follow-up (week 2)
SD derived from free-living continuous glucose monitoring
Time frame: From baseline (week 0) to follow-up (week 2)
Mean glucose derived from free-living continuous glucose monitoring
Time frame: From baseline (week 0) to follow-up (week 2)
Time in range derived from free-living continuous glucose monitoring
Time frame: From baseline (week 0) to follow-up (week 2)
Based on scores from WHO5, HAM-DS-S, and GAD-10 questionnaires
Time frame: From baseline (week 0) to follow-up (week 2)
Based on scores from WHO5 questionnaires
Time frame: From baseline (week 0) to follow-up (week 2)
Based on scores from HAM-D6-S questionnaires
Time frame: From baseline (week 0) to follow-up (week 2)
Based on scores from GAD-10 questionnaires
Time frame: From baseline (week 0) to follow-up (week 2)
Based on scores from Pittsburgh Sleep Quality Index
Time frame: From baseline (week 0) to follow-up (week 2)
Evaluated by peptidomics
Time frame: From baseline (week 0) to follow-up (week 2)
Evaluated by metabolomics
Contact information is provided by the study sponsor or research team.
Bente K Pedersen, Dr Med
CONTACT
Inge Holm
CONTACT
Rigshospitalet, Denmark
Other
The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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