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

Last updated: April 6, 2021
Sponsor: Vedic Lifesciences Pvt. Ltd.
Overall Status: Completed

Phase

N/A

Condition

Hypertriglyceridemia

Obesity

Treatment

N/A

Clinical Study ID

NCT03973086
HP/190201/CITRUSLIM/BCMH
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 screeningvisit.
  8. Unable/unwillingness to complete study specific diaries (digital/paper-based).

Study Design

Total Participants: 97
Study Start date:
June 04, 2019
Estimated Completion Date:
September 18, 2020

Connect with a study center

  • Reveal

    Bradenton, Florida 34205
    United States

    Site Not Available

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