protocolSection identificationModule nctId: NCT06320782, orgStudyIdInfo id: 4659262, briefTitle: Effects of Different Dietary Interventions on Abdominal Fat Components and Cardiometabolic Parameters., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2021-08-23, primaryCompletionDateStruct date: 2023-12-26, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Pernambuco, class: OTHER, collaborators name: Universidade Federal de Pernambuco, descriptionModule briefSummary: The study aims to evaluate the impact of different dietary interventions on abdominal fat components and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample was calculated based on data from a study with the Brazilian population, with the sample size calculated as a function of a mean difference (d) in visceral adipose tissue (VAT) after the interventions, standard deviation (s) and a significance level of 5% (z). To correct eventual losses, the number was increased by 20%. Four dietary interventions will be applied in the 6-month period: group with calorie restriction and balanced distribution of macronutrients (group 1); group with calorie restriction and low-carbohydrate diet (group 2); group with calorie restriction and low-fat diet (group 3) and group with collective nutritional guidance (group 4). Patients will be followed up monthly to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines and monitor anthropometric measurements and abdominal adipose tissue. The evaluation of VAT and subcutaneous adipose tissue (SAT) by ultrasonography will be performed at baseline and after 6 months of intervention. The present study is expected to clarify the effects that different dietary interventions produce over 6 months on abdominal fat deposits and cardiometabolic parameters., conditionsModule conditions: Abdominal Obesity, conditions: Cardiac Disease, conditions: Metabolic Disease, conditions: Cardiometabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 4 interventions distributed in a randomized manner among 4 different groups, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The data analysis and interpretation stage will be carried out by the study coordinator, who will not have knowledge about the allocation of participants among the intervention groups, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Calorie restriction and balanced distribution of macronutrients, interventions name: Calorie restriction and low-carbohydrate diet, interventions name: Calorie restriction and low-fat diet, interventions name: Collective nutritional guidance, outcomesModule primaryOutcomes measure: Thickness, measured in centimeters, of visceral adipose tissue, primaryOutcomes measure: Weight loss measured in kilograms, secondaryOutcomes measure: Serum levels of fasting glucose, secondaryOutcomes measure: Serum levels of Insulin, secondaryOutcomes measure: Serum levels Triglycerides, secondaryOutcomes measure: Serum levels Lipid profile, secondaryOutcomes measure: Serum levels C-reactive protein (hs-CRP), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Isa Galvao Rodrigues, city: Recife, state: PE, zip: 51021120, country: Brazil, geoPoint lat: -8.05389, lon: -34.88111, hasResults: False