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NCT Number: NCT06240208

Physical Inactivity and Appetite Regulation

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.

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Key information

Age range

40 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital

Copenhagen, Denmark

Location status: Recruiting

Location contact

Grit E Legård

CONTACT

[email protected]

+45 35457641

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Inactivity

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    Evaluated by visual food stimuli combined with eye tracking

  2. The change in subjective experience of severity and type of food cravings

    Time frame: From baseline (week 0) to follow-up (week 2)

    Evaluated by the Control of Eating Questionnaire.

  3. The change in subjective feeling of satiety

    Time frame: From baseline (week 0) to follow-up (week 2)

    Evaluated by a visual analogue scale

  4. The change in subjective felling of hunger

    Time frame: From baseline (week 0) to follow-up (week 2)

    Evaluated by a visual analogue scale

  5. The change in satiety composite appetite score

    Time frame: From baseline (week 0) to follow-up (week 2)

    Calculated from visual analog scales

  6. Sub study

    Time frame: Sub study

    Comparison between Ad libitum meal +/- GLP-1 infusion on primary and secondary outcomes of the primary study.

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

    Time frame: From baseline (week 0) to follow-up (week 2)

    Measured by surrogate marker paracetamol

  3. Change in body composition (body weight, body mass index, lean mass, fat mass)

    Time frame: From baseline (week 0) to follow-up (week 2)

    Based on DXA scans

  4. Change in physical fitness (maximal aerobic capacity, one repetition max)

    Time frame: From baseline (week 0) to follow-up (week 2)

  5. Change in plasma glucose during ad libitum meal

    Time frame: From baseline (week 0) to follow-up (week 2)

    AUC (mol/hour)

  6. Change in plasma insulin during ad libitum meal

    Time frame: From baseline (week 0) to follow-up (week 2)

    AUC (mol/h)

  7. Change in plasma c-peptide during ad libitum meal

    Time frame: From baseline (week 0) to follow-up (week 2)

    AUC (mol/hour)

  8. Change in glucagon supression during ad libitum meal

    Time frame: From baseline (week 0) to follow-up (week 2)

    The % glucagon supression at time 0-30min, 0-60min and 0-120min

  9. Change in plasma insulin/glucagon ratio during ad libitum meal

    Time frame: From baseline (week 0) to follow-up (week 2)

    Insulin/glucagon at time=30, 60 and 120

  10. Change in plasma glucose during mixed meal tolerance test

    Time frame: From baseline (week 0) to follow-up (week 2)

    AUC (mol/hour)

  11. Change in plasma insulin during mixed meal tolerance test

    Time frame: From baseline (week 0) to follow-up (week 2)

    AUC (mol/hour)

  12. Change in insulin/c-peptide ratio during mixed meal tolerance test

    Time frame: From baseline (week 0) to follow-up (week 2)

    Insulin/glucagon at time 30min, 60min, 120min and 180

  13. Change in plasma c-peptide during mixed meal tolerance test

    Time frame: From baseline (week 0) to follow-up (week 2)

    AUC (mol/hour)

  14. Change in glucagon supression during mixed meal tolerance test

    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

  15. Change in plasma insulin/glucagon ratio during mixed meal tolerance test

    Time frame: From baseline (week 0) to follow-up (week 2)

    Insulin/glucagon at time 30min, 60min, 120min and 180

  16. Change in plasma concentration of cytokines (IL-1Ra, IL-6, IL-10, CRP, TNF-α, GDF-15)

    Time frame: From baseline (week 0) to follow-up (week 2)

  17. Change in plasma concentration of adipokines (leptin and adiponectin)

    Time frame: From baseline (week 0) to follow-up (week 2)

  18. Change in glycaemic variability

    Time frame: From baseline (week 0) to follow-up (week 2)

    CV% derived from free-living continuous glucose monitoring

  19. Change in glycaemic variability

    Time frame: From baseline (week 0) to follow-up (week 2)

    SD derived from free-living continuous glucose monitoring

  20. Change in glycaemic variability

    Time frame: From baseline (week 0) to follow-up (week 2)

    Mean glucose derived from free-living continuous glucose monitoring

  21. Change in glycaemic variability

    Time frame: From baseline (week 0) to follow-up (week 2)

    Time in range derived from free-living continuous glucose monitoring

  22. Change in physical and mental well-being

    Time frame: From baseline (week 0) to follow-up (week 2)

    Based on scores from WHO5, HAM-DS-S, and GAD-10 questionnaires

  23. Change in physical and mental well-being

    Time frame: From baseline (week 0) to follow-up (week 2)

    Based on scores from WHO5 questionnaires

  24. Change in symptoms of depression

    Time frame: From baseline (week 0) to follow-up (week 2)

    Based on scores from HAM-D6-S questionnaires

  25. Change in symptoms of anxiety

    Time frame: From baseline (week 0) to follow-up (week 2)

    Based on scores from GAD-10 questionnaires

  26. Change in sleep Quality

    Time frame: From baseline (week 0) to follow-up (week 2)

    Based on scores from Pittsburgh Sleep Quality Index

  27. Change in plasma peptides

    Time frame: From baseline (week 0) to follow-up (week 2)

    Evaluated by peptidomics

  28. Change in plasma metabolites

    Time frame: From baseline (week 0) to follow-up (week 2)

    Evaluated by metabolomics

Study contacts

Contact information is provided by the study sponsor or research team.

Bente K Pedersen, Dr Med

CONTACT

[email protected]

+45 35 45 76 41

Inge Holm

CONTACT

[email protected]

+45 35 45 76 41

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Novo Nordisk A/S
  • TrygFonden, Denmark

Registry information

Official study title

The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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