Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-07 @ 6:24 PM
Study NCT ID:
NCT02134860
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2014-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bed Rest, Alternate Daily Fasting and Incretin Effect
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
The individual study period will be 10 days in total.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: