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OpenTrials
Completed

NCT Number: NCT03973086

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reveal

Bradenton, Florida, 34205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female participants with the age of ≥18 and ≤ 60 years of age.
  • BMI of ≥25 - ≤ 35 kg/m2
  • 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)
  • Triglycerides >150 mg/dL
  • Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg
  • Fasting blood glucose ≥ 100 mg/ dl
  • Low HDL level: Men: < 40 mg/dL, Women: < 50 mg/dL
  • 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:

  • Current smoker.
  • Inability to walk independently.
  • Presence of unstable, acutely symptomatic, or life-limiting illness.
  • Neurological conditions causing functional or cognitive impairments
  • Unwillingness or inability to be randomized to one of three intervention groups.
  • Bilateral hip replacements.
  • Exposure to any non-registered drug product within 3 months prior to the screening visit.
  • Unable/unwillingness to complete study specific diaries (digital/paper-based).

Treatment and study plan

Citrus flavonone-O-glycosides- LD

Dietary Supplement

Low Dose of 200 mg

Citrus flavonone-O-glycosides- HD

Dietary Supplement

High Dose of 400 mg

Placebo

Dietary Supplement

Placebo (Microcrystalline Cellulose) of 400 mg

Primary outcomes

  1. Change in body fat percent Body Mass Index (kg/m2)

    Time frame: 16 weeks.

    Assessed using DEXA

  2. Change in Lean Body Mass (g)

    Time frame: 16 weeks

    Assessed using DEXA

  3. Change in Body Fat (%)

    Time frame: 16 weeks

    Assessed using DEXA

  4. Change in Fat Free Mass (g)

    Time frame: 16 weeks

    Assessed using DEXA

Sponsors and collaborators

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2019
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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