Physical Inactivity and Appetite Regulation

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240208
• Other study ID #: H-23055497
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Rigshospitalet, Denmark
• Contact: Inge Holm
• Phone: +45 35 45 76 41
• Email: inge.holm[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Novo Nordisk A/S, TrygFonden, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in secretion of gut hormones (GLP-1, GIP, PYY, ghrelin, CCK)		From baseline (week 0) to follow-up (week 2)
Other	Change in gastric emptying rate	Measured by surrogate marker paracetamol	From baseline (week 0) to follow-up (week 2)
Other	Change in body composition (body weight, body mass index, lean mass, fat mass)	Based on DXA scans	From baseline (week 0) to follow-up (week 2)
Other	Change in physical fitness (maximal aerobic capacity, one repetition max)		From baseline (week 0) to follow-up (week 2)
Other	Change in plasma glucose during ad libitum meal	AUC (mol/hour)	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma insulin during ad libitum meal	AUC (mol/h)	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma c-peptide during ad libitum meal	AUC (mol/hour)	From baseline (week 0) to follow-up (week 2)
Other	Change in glucagon supression during ad libitum meal	The % glucagon supression at time 0-30min, 0-60min and 0-120min	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma insulin/glucagon ratio during ad libitum meal	Insulin/glucagon at time=30, 60 and 120	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma glucose during mixed meal tolerance test	AUC (mol/hour)	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma insulin during mixed meal tolerance test	AUC (mol/hour)	From baseline (week 0) to follow-up (week 2)
Other	Change in insulin/c-peptide ratio during mixed meal tolerance test	Insulin/glucagon at time 30min, 60min, 120min and 180	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma c-peptide during mixed meal tolerance test	AUC (mol/hour)	From baseline (week 0) to follow-up (week 2)
Other	Change in glucagon supression during mixed meal tolerance test	The % glucagon supression at time 0-30min, 0-60min, 0-120min and 0-180	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma insulin/glucagon ratio during mixed meal tolerance test	Insulin/glucagon at time 30min, 60min, 120min and 180	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma concentration of cytokines (IL-1Ra, IL-6, IL-10, CRP, TNF-a, GDF-15)		From baseline (week 0) to follow-up (week 2)
Other	Change in plasma concentration of adipokines (leptin and adiponectin)		From baseline (week 0) to follow-up (week 2)
Other	Change in glycaemic variability	CV% derived from free-living continuous glucose monitoring	From baseline (week 0) to follow-up (week 2)
Other	Change in glycaemic variability	SD derived from free-living continuous glucose monitoring	From baseline (week 0) to follow-up (week 2)
Other	Change in glycaemic variability	Mean glucose derived from free-living continuous glucose monitoring	From baseline (week 0) to follow-up (week 2)
Other	Change in glycaemic variability	Time in range derived from free-living continuous glucose monitoring	From baseline (week 0) to follow-up (week 2)
Other	Change in physical and mental well-being	Based on scores from WHO5, HAM-DS-S, and GAD-10 questionnaires	From baseline (week 0) to follow-up (week 2)
Other	Change in physical and mental well-being	Based on scores from WHO5 questionnaires	From baseline (week 0) to follow-up (week 2)
Other	Change in symptoms of depression	Based on scores from HAM-D6-S questionnaires	From baseline (week 0) to follow-up (week 2)
Other	Change in symptoms of anxiety	Based on scores from GAD-10 questionnaires	From baseline (week 0) to follow-up (week 2)
Other	Change in sleep Quality	Based on scores from Pittsburgh Sleep Quality Index	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma peptides	Evaluated by peptidomics	From baseline (week 0) to follow-up (week 2)
Other	Change in plasma metabolites	Evaluated by metabolomics	From baseline (week 0) to follow-up (week 2)
Primary	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	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	From baseline (week 0) to follow-up (week 2)
Secondary	The change in subjective experience of severity and type of food cravings	Evaluated by the Control of Eating Questionnaire.	From baseline (week 0) to follow-up (week 2)
Secondary	The change in subjective feeling of satiety	Evaluated by a visual analogue scale	From baseline (week 0) to follow-up (week 2)
Secondary	The change in subjective felling of hunger	Evaluated by a visual analogue scale	From baseline (week 0) to follow-up (week 2)
Secondary	The change in satiety composite appetite score	Calculated from visual analog scales	From baseline (week 0) to follow-up (week 2)