Physical Inactivity and Appetite Regulation

NCT06240208 | Recruiting

• 1 other identifier: H-23055497
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Outcome Measures

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

  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).

  From baseline (week 0) to follow-up (week 2)

• The change in subjective experience of severity and type of food cravings

  From baseline (week 0) to follow-up (week 2)

• The change in subjective feeling of satiety

  From baseline (week 0) to follow-up (week 2)

• The change in subjective felling of hunger

  From baseline (week 0) to follow-up (week 2)

• The change in satiety composite appetite score

  From baseline (week 0) to follow-up (week 2)

Other Outcomes (28)

• Change in secretion of gut hormones (GLP-1, GIP, PYY, ghrelin, CCK)

  From baseline (week 0) to follow-up (week 2)

• Change in gastric emptying rate

  From baseline (week 0) to follow-up (week 2)

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

  From baseline (week 0) to follow-up (week 2)

Study Arms (2)

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.

Behavioral: Inactivity

Control

NO INTERVENTION

Participants will be instructed to maintain habitual physical activity and dietary habits.

Interventions

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.

Inactivity

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: collaborator
• TrygFonden, Denmark: collaborator
• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen University Hospital

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Grit Elster Legård, MD, PhD

  Centre for Physical Activity Research, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inge Holm

CONTACT

+45 35 45 76 41; inge.holm@regionh.dk

Bente K Pedersen, Dr Med

CONTACT

+45 35 45 76 41; Bente.Klarlund.Pedersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 2, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)