protocolSection identificationModule nctId: NCT06381908, orgStudyIdInfo id: 1-10-72-19-24, briefTitle: The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity, acronym: CHO-EX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, collaborators name: University of Southern Denmark, collaborators name: University Ghent, descriptionModule 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., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Calorie-restriction with low carbohydrate, interventions name: Calorie-restriction with moderate carbohydrate, outcomesModule primaryOutcomes measure: Time to exhaustion, primaryOutcomes measure: Sprint performance, primaryOutcomes measure: Exercise tolerance, primaryOutcomes measure: Muscle glycogen levels, secondaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Maximal fat oxidation capacity, secondaryOutcomes measure: Muscle metabolic enzyme activity, secondaryOutcomes measure: Blood lipid profile, secondaryOutcomes measure: Continuous glucose levels, secondaryOutcomes measure: Fasting blood glucose and insulin, secondaryOutcomes measure: Long-term glycemic control (HbAc1), eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Section for Sport Science, Department of Public Health, Aarhus University, status: RECRUITING, city: Aarhus C, zip: 8000, country: Denmark, contacts name: Mette Hansen, PhD, role: CONTACT, phone: +4551666551, email: mhan@ph.au.dk, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False