OverweightNCT06240208
Physical Inactivity and Appetite Regulation
A study testing Inactivity in people with Overweight, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Inactivity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 26Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital
Copenhagen
Grit E Legård, +45 35457641, grit.elster.legaard@regionh.dk
About this study
Official title: The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study
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:
Read more
- 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Inactivity
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InactivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Inactivity | Experimental | 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. Receives: Behavioral: Inactivity |
| Control | No intervention | Participants will be instructed to maintain habitual physical activity and dietary habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in food intake at an ad libitum meal during GLP-1 infusion
Food intake will be evaluated as ingested food in grams
Measured: From baseline (week 0) to follow-up (week 2).
Secondary outcomes (6)
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
Measured: From baseline (week 0) to follow-up (week 2)
The change in subjective experience of severity and type of food cravings
Evaluated by the Control of Eating Questionnaire.
Measured: From baseline (week 0) to follow-up (week 2)
The change in subjective feeling of satiety
Evaluated by a visual analogue scale
Measured: From baseline (week 0) to follow-up (week 2)
The change in subjective felling of hunger
Evaluated by a visual analogue scale
Measured: From baseline (week 0) to follow-up (week 2)
The change in satiety composite appetite score
Calculated from visual analog scales
Measured: From baseline (week 0) to follow-up (week 2)
Sub study
Comparison between Ad libitum meal +/- GLP-1 infusion on primary and secondary outcomes of the primary study.
Measured: Sub study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Mar 2024
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, TrygFonden, Denmark
- Responsible party
- Principal investigator, Grit Elster Legård, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Grit Elster Legård, MD, PhD, Principal investigator, Centre for Physical Activity Research, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240208
- Sponsor's protocol ID
- H-23055497
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If the data can be fully anonymized the data can be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study
- ClinicalTrials.gov ID
- NCT06240208
- Acronym / sponsor ID
- H-23055497
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, TrygFonden, Denmark
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactivity | Experimental | Behavioral: InactivityInactivity 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. |
| Control | No intervention | –Participants will be instructed to maintain habitual physical activity and dietary habits. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InactivityInactivity 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. | Behavioural | Inactivity |
Primary outcome
The change in food intake at an ad libitum meal during GLP-1 infusion
Time frame: From baseline (week 0) to follow-up (week 2).
Food intake will be evaluated as ingested food in grams
6 secondary outcomes
The change in preference for unhealthy food ( combined score for high fat food, savory food, and sweet food).
Time frame: From baseline (week 0) to follow-up (week 2)
The change in subjective experience of severity and type of food cravings
Time frame: From baseline (week 0) to follow-up (week 2)
The change in subjective feeling of satiety
Time frame: From baseline (week 0) to follow-up (week 2)
The change in subjective felling of hunger
Time frame: From baseline (week 0) to follow-up (week 2)
The change in satiety composite appetite score
Time frame: From baseline (week 0) to follow-up (week 2)
Sub study
Time frame: Sub study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No. If the data can be fully anonymized the data can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grit Elster Legård, MD, PhD principal investigator
Centre for Physical Activity Research, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactivity in people with Overweight, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inge Holm (+45 35 45 76 41, inge.holm@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in food intake at an ad libitum meal during GLP-1 infusion (time frame: From baseline (week 0) to follow-up (week 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.