Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381908
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-05
Brief Title:
The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity and Health in Overweight Women
Status:
RECRUITING
Status Verified Date:
2024-04
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:
CHO-EX
Brief Summary:
The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity metabolism and metabolic health indicators will be measured in a randomized parallel group design Forty overweight BMI 25-30 and relatively inactive women 20-35 of age will be included These will be randomized into one of two experimental groups both receiving a calorie-restricted diet -1000 kcal combined with either low carbohydrate availability or moderate carbohydrate availability across a 10 day period Laboratory-based physical capacity tests and blood and muscle sampling will be performed before and after the intervention In addition an additional follow-up test day will be performed after continuing the diet for another 48 h and then standardizing the pre-testing carbohydrate availability before repeating the tests of physical capacity
Detailed Description:
Overweight BMI 25-30 but healthy premenopausal women aged 20-35 years n40 will be included in the trial which is structured as a randomized parallel group design where participants are randomized to either consume a hypocaloric diet -1000 kcal with concurrent carbohydrate restriction low carbohydrate L-CHO n20 or a similar hypocaloric diet with moderate carbohydrate availability moderate carbohydrate M-CHO n20 The trial will be single-blinded since it might be transparent to the participants which diet they are consuming whereas the test personnel collecting and processing test results will be blinded to diet allocation Diet handling will be managed by specific individuals in the research group who do not partake in executing the physical capacity tests Additionally the direction of the trials primary hypothesis will not be disclosed to the participants to avoid creating preconceived expectations about the effects
After an initial screening interview and two familiarization visits participants will complete the intervention period consisting of 10 days with the allocated diet manipulation with preceding and subsequent test days with a series of tests The tests before and after each test period include measurements of the participants physical capacity level and energy metabolism in the laboratory as well as blood and muscle sampling In addition resting metabolism and body composition will be measured During each test period participants habitual activity level will be monitored with an accelerometer attached to the wrist Axivity There will also be monitoring of the activity level with an accelerometer in a 7-day cycle before the start of the trial as a baseline measurement
Similarly a glucose monitor will be placed on the upper arm for continuous glucose readings via a Freestyle Libre2 sensor during the trial period
After an initial screening interview and two familiarization visits participants will complete the intervention period consisting of 10 days with the allocated diet manipulation with preceding and subsequent test days with a series of tests The tests before and after each test period include measurements of the participants physical capacity level and energy metabolism in the laboratory as well as blood and muscle sampling In addition resting metabolism and body composition will be measured During each test period participants habitual activity level will be monitored with an accelerometer attached to the wrist Axivity There will also be monitoring of the activity level with an accelerometer in a 7-day cycle before the start of the trial as a baseline measurement
Similarly a glucose monitor will be placed on the upper arm for continuous glucose readings via a Freestyle Libre2 sensor during the trial period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None