Clinical trial NCT06240208: Physical Inactivity and Appetite Regulation
Official title: The Effects of Inactivity on GLP-1 Stimulated Appetite Regulation in Healthy Normal Weight Males: A Randomised, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: TrygFonden, Denmark
First posted: 2024-02-02
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Male
2. Age ≥ 40 years and ≤ 55 years
3. Body mass index (BMI) \> 20 and \< 25 kg/m2
4. 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.
5. Healthy (based on self-reporting, pre-study medical examination and biochemical screening)
6. Can adhere to two weeks of inactivity (refrain from running, cycling and all other exercise while reducing steps to max. 1500 pr. day)
7. Caucasian
8. No change in body weight \> 5 kg within the last 6 months
9. Eats breakfast and lunch daily
10. Does not follow specific dietary restrictions
11. No disliking of spaghetti bolognese
12. No diagnosis of psychiatric disorder or treatment with anti-depressant or anti-psychotic medication
13. No history of suicidal behavior or ideations.
14. No previous surgical treatment for obesity
15. No cardiovascular disease
16. No rheumatologic disease
17. No metabolic/endocrine disease
18. No liver disease (ASAT or ALAT \>2x upper normal range)
19. No other chronic disease
20. No elite sports
21. No frequent or chronic use of medications affecting bodyweight, physical performance, or inflammation (NSAIDS, DMARDS, corticosteroids)
22. No current infection
23. No history of cancer
24. No anemia (hematocrit \<33%)
25. No smoking
26. No participation in other research intervention studies

Exclusion Criteria:

1. Clinical or biochemical signs of disease
2. HbA1c \> 39 mmol/mol
3. Unable to allocate the needed time to fulfill the intervention
4. Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions

Primary outcomes:
measure: The change in food intake at an ad libitum meal during GLP-1 infusion
timeFrame: From baseline (week 0) to follow-up (week 2).
Secondary outcomes:
measure: The change in preference for unhealthy food ( combined score for high fat food, savory food, and sweet food).
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: The change in subjective experience of severity and type of food cravings
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: The change in subjective feeling of satiety
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: The change in subjective felling of hunger
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: The change in satiety composite appetite score
timeFrame: From baseline (week 0) to follow-up (week 2)
Other outcomes:
measure: Change in secretion of gut hormones (GLP-1, GIP, PYY, ghrelin, CCK)
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in gastric emptying rate
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in body composition (body weight, body mass index, lean mass, fat mass)
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in physical fitness (maximal aerobic capacity, one repetition max)
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma glucose during ad libitum meal
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma insulin during ad libitum meal
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma c-peptide during ad libitum meal
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in glucagon supression during ad libitum meal
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma insulin/glucagon ratio during ad libitum meal
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma glucose during mixed meal tolerance test
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma insulin during mixed meal tolerance test
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in insulin/c-peptide ratio during mixed meal tolerance test
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma c-peptide during mixed meal tolerance test
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in glucagon supression during mixed meal tolerance test
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma insulin/glucagon ratio during mixed meal tolerance test
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma concentration of cytokines (IL-1Ra, IL-6, IL-10, CRP, TNF-α, GDF-15)
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma concentration of adipokines (leptin and adiponectin)
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in glycaemic variability
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in glycaemic variability
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in glycaemic variability
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in glycaemic variability
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in physical and mental well-being
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in physical and mental well-being
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in symptoms of depression
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in symptoms of anxiety
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in sleep Quality
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma peptides
timeFrame: From baseline (week 0) to follow-up (week 2)
measure: Change in plasma metabolites
timeFrame: From baseline (week 0) to follow-up (week 2)
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
Study officials:
affiliation: Centre for Physical Activity Research, Rigshospitalet
name: Grit Elster Legård, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: