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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isocaloric diet | Active Comparator | 3 daily meals |
|
| Alternate daily fasting | Active Comparator | One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bed rest | Other | 8 days of full bed rest |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incretin effect | Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT) | 24 weeks |
| Cognitive function | Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI) | 18 months |
| Insulin resistance | Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Majlund Harder-Lauridsen, MD | Rigshospitalet, 7641 | Principal Investigator |
| Signe Tellerup Nielsen, MD | Rigshospitalet, 7641 | Principal Investigator |
| Rikke Krogh-Madsen, MD. PhD | Rigshospitalet, 7641 | Principal Investigator |
| Bente Klarlund Pedersen, Professor | Rigshospitalet, 7641 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512717 | Derived | 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. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D001510 | Bed Rest |
| D005951 | Glucose Tolerance Test |
| D009483 | Neuropsychological Tests |
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
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| OGTT |
| Other |
Oral glucose tolerance test with 75 g of glucose before and after bed rest |
|
| IVGTT | Other | Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT |
|
| Cognitive testing | Other | Daily testing of memory and concentration using standardized tests |
|
| Muscle and fat biopsies | Other | Biopsies will be obtained before and after bed rest |
|
| Dual-energy X-ray Absorptiometry (DXA) scan | Other | DXA scan to evaluate fat and muscle distribution before and after bed rest |
|
| MRI | Other | Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |