Bed Rest, Alternate Daily Fasting and Incretin Effect

NCT02134860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-09-22

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Nina Majlund Harder-Lauridsen, MD · Rigshospitalet, 7641

  • Signe Tellerup Nielsen, MD · Rigshospitalet, 7641

  • Rikke Krogh-Madsen, MD. PhD · Rigshospitalet, 7641

  • Bente Klarlund Pedersen, Professor · Rigshospitalet, 7641

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134860 on ClinicalTrials.gov