Bed Rest, Alternate Daily Fasting and Incretin Effect

September 19, 2014 updated by: Anders Rasmussen Rinnov, Rigshospitalet, Denmark

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:

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
Active Comparator: Alternate daily fasting
One meal (25% of caloric need) every second day and four meals (175% of caloric need) every second day
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

September 1, 2014

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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