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Bed Rest, Alternate Daily Fasting and Incretin Effect

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ClinicalTrials.gov Identifier: NCT02134860
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
Anders Rasmussen Rinnov, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE April 29, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date September 22, 2014
Study Start Date  ICMJE June 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2014)
  • Incretin effect [ Time Frame: 24 weeks ]
    Measured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)
  • Cognitive function [ Time Frame: 18 months ]
    Evaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)
  • Insulin resistance [ Time Frame: 12 weeks ]
    Evaluated by insulin resistance indexes, HOMA-IR and Matsuda index
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Incretin effect [ Time Frame: 24 weeks ]
    Measured by Insulin levels during OGTT and IVGTT
  • Cognitive function [ Time Frame: 18 months ]
    Evaluated by cognitive testing and functional MRI
  • Insulin resistance [ Time Frame: 12 weeks ]
    Evaluated by HOMA-IR and Matsuda index
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bed Rest, Alternate Daily Fasting and Incretin Effect
Official Title  ICMJE A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
Brief Summary

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:

  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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Metabolic Syndrome
  • Type 2 Diabetes
  • Critical Illness
Intervention  ICMJE
  • Other: Bed rest
    8 days of full bed rest
  • Other: OGTT
    Oral glucose tolerance test with 75 g of glucose before and after bed rest
  • Other: IVGTT
    Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
  • Other: Cognitive testing
    Daily testing of memory and concentration using standardized tests
  • Other: Muscle and fat biopsies
    Biopsies will be obtained before and after bed rest
  • Other: Dual-energy X-ray Absorptiometry (DXA) scan
    DXA scan to evaluate fat and muscle distribution before and after bed rest
  • Other: MRI
    Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
Study Arms  ICMJE
  • Active Comparator: Isocaloric diet
    3 daily meals
    Interventions:
    • Other: Bed rest
    • Other: OGTT
    • Other: IVGTT
    • Other: Cognitive testing
    • Other: Muscle and fat biopsies
    • Other: Dual-energy X-ray Absorptiometry (DXA) scan
    • Other: MRI
  • Active Comparator: Alternate daily fasting
    One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
    Interventions:
    • Other: Bed rest
    • Other: OGTT
    • Other: IVGTT
    • Other: Cognitive testing
    • Other: Muscle and fat biopsies
    • Other: Dual-energy X-ray Absorptiometry (DXA) scan
    • Other: MRI
Publications * 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:CD013496. doi: 10.1002/14651858.CD013496.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134860
Other Study ID Numbers  ICMJE H-6-2014-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Anders Rasmussen Rinnov, Rigshospitalet, Denmark
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rigshospitalet, Denmark
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Rigshospitalet, Denmark
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP