protocolSection identificationModule nctId: NCT06344377, orgStudyIdInfo id: BETadiposeWOMEN, briefTitle: Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-21, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Poznan University of Life Sciences, class: OTHER, descriptionModule briefSummary: Obesity represents a serious global health issue with significant consequences, including an increased risk of chronic diseases. Statistics indicate a growing trend of obesity, highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications. Previous research on animals has shown that betaine, a substance engaged in one-carbon metabolism, may enhance fat oxidation and lower adipose tissue. Therefore, the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers, as well as expression of genes related to lipid metabolism, in a group of adult women with abdominal obesity.This study is designed in a placebo-controlled, double-blinded, randomized fashion. The participants will be overweight or obese pre-menopausal females. Upon enrollment, participants will be randomly assigned to one of two parallel groups: betaine (3g/d) or placebo. The supplementation period will last for 8 weeks. There will be three study meetings: T1 before supplementation, T2 after 4 weeks of supplementation, and T3 after 8 weeks of supplementation. Blood will be drawn and body composition measured, and adipose tissue biopsy taken at meetings T1 and T3. The T2 meeting will involve only body composition measurement. Study outcomes will include body mass and composition (including body fat percent), lipid profile, and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Betaine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Body composition, primaryOutcomes measure: Body mass, primaryOutcomes measure: Waist and hips circumference, primaryOutcomes measure: Lipid profile, primaryOutcomes measure: Gene expression, secondaryOutcomes measure: Liver function test, secondaryOutcomes measure: Dietary intake, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Poznan University of Life Sciences, city: Poznań, zip: 60-637, country: Poland, contacts name: Agata Chmurzynska, role: CONTACT, phone: +48 618466181, email: agata.chmurznska@up.poznan.pl, contacts name: Agata Chmurzynska, role: PRINCIPAL_INVESTIGATOR, contacts name: Emilia Zawieja, role: SUB_INVESTIGATOR, contacts name: Monika Młodzik-Czyżewska, role: SUB_INVESTIGATOR, contacts name: Paweł Juszczak, role: SUB_INVESTIGATOR, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False