- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02134860
Bed Rest, Alternate Daily Fasting and Incretin Effect
A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
Bed rest produces insulin resistance in healthy volunteers. In this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest.
The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need).
The investigators hypothesize:
- Bed rest reduces the incretin effect
- Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet
- Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet
Study Overview
Status
Conditions
Detailed Description
All subjects will undergo 8 days of bedrest. Outcome measures will be performed before, under and immediately after the bed rest period.
The individual study period will be 10 days in total.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark
- Rigshospitalet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI<25kg/m2
- VO2 max normal for age
Exclusion Criteria:
- Tobacco smoking
- Alcohol ingestion > 14 units per week
- Diabetes in nearby relatives
- Resection of the small intestine
- History of gastric bypass surgery
- Risk of deep venous thrombosis
- Female
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Isocaloric diet
3 daily meals
|
8 days of full bed rest
Oral glucose tolerance test with 75 g of glucose before and after bed rest
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
Daily testing of memory and concentration using standardized tests
Biopsies will be obtained before and after bed rest
DXA scan to evaluate fat and muscle distribution before and after bed rest
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
|
Active Comparator: Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
|
8 days of full bed rest
Oral glucose tolerance test with 75 g of glucose before and after bed rest
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
Daily testing of memory and concentration using standardized tests
Biopsies will be obtained before and after bed rest
DXA scan to evaluate fat and muscle distribution before and after bed rest
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incretin effect
Time Frame: 24 weeks
|
Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)
|
24 weeks
|
Cognitive function
Time Frame: 18 months
|
Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)
|
18 months
|
Insulin resistance
Time Frame: 12 weeks
|
Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nina Majlund Harder-Lauridsen, MD, Rigshospitalet, 7641
- Principal Investigator: Signe Tellerup Nielsen, MD, Rigshospitalet, 7641
- Principal Investigator: Rikke Krogh-Madsen, MD. PhD, Rigshospitalet, 7641
- Study Director: Bente Klarlund Pedersen, Professor, Rigshospitalet, 7641
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-6-2014-017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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