Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-06-30
2014-09-30
Brief Summary
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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:
1. Bed rest reduces the incretin effect
2. Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet
3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet
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Detailed Description
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The individual study period will be 10 days in total.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Isocaloric diet
3 daily meals
Bed rest
8 days of full bed rest
OGTT
Oral glucose tolerance test with 75 g of glucose before and after bed rest
IVGTT
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
Cognitive testing
Daily testing of memory and concentration using standardized tests
Muscle and fat biopsies
Biopsies will be obtained before and after bed rest
Dual-energy X-ray Absorptiometry (DXA) scan
DXA scan to evaluate fat and muscle distribution before and after bed rest
MRI
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
Bed rest
8 days of full bed rest
OGTT
Oral glucose tolerance test with 75 g of glucose before and after bed rest
IVGTT
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
Cognitive testing
Daily testing of memory and concentration using standardized tests
Muscle and fat biopsies
Biopsies will be obtained before and after bed rest
Dual-energy X-ray Absorptiometry (DXA) scan
DXA scan to evaluate fat and muscle distribution before and after bed rest
MRI
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
Interventions
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Bed rest
8 days of full bed rest
OGTT
Oral glucose tolerance test with 75 g of glucose before and after bed rest
IVGTT
Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
Cognitive testing
Daily testing of memory and concentration using standardized tests
Muscle and fat biopsies
Biopsies will be obtained before and after bed rest
Dual-energy X-ray Absorptiometry (DXA) scan
DXA scan to evaluate fat and muscle distribution before and after bed rest
MRI
Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
Eligibility Criteria
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Inclusion Criteria
* VO2 max normal for age
Exclusion Criteria
* 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
18 Years
35 Years
MALE
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Anders Rasmussen Rinnov
MD, PhD
Principal Investigators
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Nina Majlund Harder-Lauridsen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, 7641
Signe Tellerup Nielsen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, 7641
Rikke Krogh-Madsen, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, 7641
Bente Klarlund Pedersen, Professor
Role: STUDY_DIRECTOR
Rigshospitalet, 7641
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Other Identifiers
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H-6-2014-017
Identifier Type: -
Identifier Source: org_study_id
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