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

April 6, 2021 updated by: Vedic Lifesciences Pvt. Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34205
        • Reveal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Citrus flavonone-O-glycosides (Low dose)
Dietary supplement: Citrus flavonone-O-glycosides- LD
Low Dose of 200 mg
Experimental: Citrus flavonone-O-glycosides (High dose)
Dietary supplement: Citrus flavonone-O-glycosides- HD
High Dose of 400 mg
Placebo Comparator: Microcrystaline Cellulose- 400mg
Dietary supplement: Placebo
Placebo (Microcrystalline Cellulose) of 400 mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vedic Lifesciences Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2019

Primary Completion (Actual)

May 30, 2020

Study Completion (Actual)

September 18, 2020

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

June 1, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP/190201/CITRUSLIM/BCMH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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