To Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals

Overview

CitruSlim® can promote healthy weight loss by promoting anabolic state during weight loss programs, prevent the body from storing fat, reduce appetites and maintain healthy cholesterol and blood glucose level during weight loss program. This study focuses to prove the efficacy and safety of the product in a population of overweight and obese individual.

Full Title of Study: “A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 30, 2020

Interventions

  • Dietary Supplement: Citrus flavonone-O-glycosides- LD
    • Low Dose of 200 mg
  • Dietary Supplement: Citrus flavonone-O-glycosides- HD
    • High Dose of 400 mg
  • Dietary Supplement: Placebo
    • Placebo (Microcrystalline Cellulose) of 400 mg

Arms, Groups and Cohorts

  • Experimental: Citrus flavonone-O-glycosides (Low dose)
  • Experimental: Citrus flavonone-O-glycosides (High dose)
  • Placebo Comparator: Microcrystaline Cellulose- 400mg

Clinical Trial Outcome Measures

Primary Measures

  • Change in body fat percent Body Mass Index (kg/m2)
    • Time Frame: 16 weeks.
    • Assessed using DEXA
  • Change in Lean Body Mass (g)
    • Time Frame: 16 weeks
    • Assessed using DEXA
  • Change in Body Fat (%)
    • Time Frame: 16 weeks
    • Assessed using DEXA
  • Change in Fat Free Mass (g)
    • Time Frame: 16 weeks
    • Assessed using DEXA

Participating in This Clinical Trial

Inclusion Criteria

1. Male and female participants with the age of ≥18 and ≤ 60 years of age. 2. BMI of ≥25 – ≤ 35 kg/m2 3. Waist circumference:India: Men: > 94 cm (37 inches), Women: >80 cm (31.5 inches) USA: Men: > 102 cm (40 inches), Women: >89 cm (35 inches) 4. Triglycerides >150 mg/dL 5. Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg 6. Fasting blood glucose ≥ 100 mg/ dl 7. Low HDL level: Men: < 40 mg/dL, Women: < 50 mg/dL 8. Ready to give voluntary, written, informed consent to participate in the study. Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the trial: 1. Current smoker. 2. Inability to walk independently. 3. Presence of unstable, acutely symptomatic, or life-limiting illness. 4. Neurological conditions causing functional or cognitive impairments 5. Unwillingness or inability to be randomized to one of three intervention groups. 6. Bilateral hip replacements. 7. Exposure to any non-registered drug product within 3 months prior to the screening visit. 8. Unable/unwillingness to complete study specific diaries (digital/paper-based).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vedic Lifesciences Pvt. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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