Skip to content

Bed Rest, Alternate Daily Fasting and Incretin Effect

A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02134860
Enrollment
20
Registered
2014-05-09
Start date
2014-06-30
Completion date
2014-09-30
Last updated
2014-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Type 2 Diabetes, Critical Illness

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.

Interventions

8 days of full bed rest

OTHEROGTT

Oral glucose tolerance test with 75 g of glucose before and after bed rest

OTHERIVGTT

Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT

OTHERCognitive testing

Daily testing of memory and concentration using standardized tests

OTHERMuscle and fat biopsies

Biopsies will be obtained before and after bed rest

DXA scan to evaluate fat and muscle distribution before and after bed rest

OTHERMRI

Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incretin effect24 weeksMeasured by Insulin levels during Oral glucose tolerance test (OGTT) and Intravenous glucose tolerance test (IVGTT)
Cognitive function18 monthsEvaluated by cognitive testing and functional Magnetic Resonance imaging (MRI)
Insulin resistance12 weeksEvaluated by insulin resistance indexes, HOMA-IR and Matsuda index

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026