nctId: NCT06381908 id: 1-10-72-19-24 briefTitle: The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity acronym: CHO-EX overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-15 date: 2024-12-15 date: 2024-04-24 date: 2024-04-24 name: University of Aarhus class: OTHER name: University of Southern Denmark name: University Ghent briefSummary: 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. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is performed as a randomized single-blinded parallel group design. Randomization is performed into two groups using minimization based on a predetermined estimated VO2max middle value of 30. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The study is labelled as a single-blinded study because the investigators are blinded to the group allocation (the group allocation and diet handling is managed by a researcher not involved in other aspects of the data collection or processing). The participants are not informed about their allocated condition, however, it is conceivably possible for them to recognize this based on the food provided. However, the direction of the hypothesis will not be evident to the participants. Moreover, we include questionnaires before the post-tests related to their perceived diet allocation and their perception of the effect of the diet on the test assessments. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Calorie-restriction with low carbohydrate name: Calorie-restriction with moderate carbohydrate measure: Time to exhaustion measure: Sprint performance measure: Exercise tolerance measure: Muscle glycogen levels measure: Physical activity level measure: Maximal fat oxidation capacity measure: Muscle metabolic enzyme activity measure: Blood lipid profile measure: Continuous glucose levels measure: Fasting blood glucose and insulin measure: Long-term glycemic control (HbAc1) sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Section for Sport Science, Department of Public Health, Aarhus University status: RECRUITING city: Aarhus C zip: 8000 country: Denmark name: Mette Hansen, PhD role: CONTACT phone: +4551666551 email: mhan@ph.au.dk lat: 56.15674 lon: 10.21076 hasResults: False