Section for Sport Science, Department of Public Health, Aarhus University
Aarhus C, 8000, Denmark
NCT Number: NCT06381908
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.
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Notify Me20 year–35 year
Female
Interventional
Not applicable
Aarhus C, 8000, Denmark
Overweight (BMI 25-30), but healthy premenopausal women aged 20-35 years (n=40) 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, n=20) or a similar hypocaloric diet with moderate carbohydrate availability (moderate carbohydrate, M-CHO, n=20). 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 trial's 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Calorie-restriction and low carbohydrate availability
Calorie-restriction and moderate carbohydrate availability
Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Time to exhaustion at 85% VO2max
Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Peak and mean 15-s sprint performance
Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Ratings of perceived exertion (Borg scale) during standardized-intensity exercise from 6 (lowest exertion) to 20 (highest exertion)
Time frame: Pre and post (day 11 of the intervention)
Muscle glycogen levels obtained from biopsy sample
Time frame: During the intervention (days 1 to 11 of the intervention)
Measured with accelerometer during the intervention
Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Maximal fat oxidation measured in the laboratory
Time frame: Pre and post (day 11 of the intervention)
Activity of key enzymes involved in carbohydrate and fat metabolism
Time frame: Pre and post (day 11 of the intervention)
High-density lipoproteins, low-density lipoproteins, very-low-density lipoproteins, cholesterol, free fatty acids and triglycerides
Time frame: 14 days from the day before the intervention, throughout the intervention (days 1 to 11) and 2 days after the intervention (follow-up)
Glucose levels measured continuously across the trial + during exercise tests
Time frame: Pre and post (day 11 of the intervention)
Insulin sensitivity (Homa 2 IR)
Time frame: Pre and post (day 11 of the intervention)
Measured from fasting blood
University of Aarhus
Other
The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity and Health in Overweight Women
Acronym: CHO-EX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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