protocolSection identificationModule nctId: NCT06296251, orgStudyIdInfo id: BIO-2313, briefTitle: Dietary Supplementation on Body Fat Composition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-12-27, completionDateStruct date: 2025-02-27, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Brightseed, class: INDUSTRY, descriptionModule briefSummary: The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo., conditionsModule conditions: Dyslipidemias, conditions: Pre-diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Placebo treatment, interventions name: Plant derived phenolics, outcomesModule primaryOutcomes measure: Body fat mass, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Android fat mass, secondaryOutcomes measure: Gynoid fat mass, secondaryOutcomes measure: Abdominal visceral fat mass, secondaryOutcomes measure: Abdominal circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Chest circumference, secondaryOutcomes measure: Upper thigh circumference, secondaryOutcomes measure: Upper arm circumference, secondaryOutcomes measure: Waist to hip ratio, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Fasting insulin, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: FGF21, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Total-Cholesterol, secondaryOutcomes measure: HDL-C, secondaryOutcomes measure: LDL-C, secondaryOutcomes measure: VLDL-C, secondaryOutcomes measure: non-HDL-C, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Body Weight, secondaryOutcomes measure: Physical functioning, secondaryOutcomes measure: Bodily pain, secondaryOutcomes measure: Role limitations due to physical health, secondaryOutcomes measure: Role limitation due to personal or emotional problems, secondaryOutcomes measure: Emotional well-being, secondaryOutcomes measure: Social functioning, secondaryOutcomes measure: Energy/Fatigue, secondaryOutcomes measure: General health perceptions, secondaryOutcomes measure: Total kcals, secondaryOutcomes measure: Total fat, secondaryOutcomes measure: Total protein, secondaryOutcomes measure: Total carbohydrates, secondaryOutcomes measure: Fiber, secondaryOutcomes measure: Healthy Eating Index (HEI) score, secondaryOutcomes measure: ALT, secondaryOutcomes measure: AST, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False