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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Citrus flavonone-O-glycosides- LD
Citrus flavonone-O-glycosides- HD
Placebo
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Reveal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Citrus flavonone-O-glycosides (Low dose)

Citrus flavonone-O-glycosides (High dose)

Microcrystaline Cellulose- 400mg

Arm Description

Outcomes

Primary Outcome Measures

Change in body fat percent Body Mass Index (kg/m2)
Assessed using DEXA
Change in Lean Body Mass (g)
Assessed using DEXA
Change in Body Fat (%)
Assessed using DEXA
Change in Fat Free Mass (g)
Assessed using DEXA

Secondary Outcome Measures

Full Information

First Posted
May 7, 2019
Last Updated
April 6, 2021
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03973086
Brief Title
To Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
September 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citrus flavonone-O-glycosides (Low dose)
Arm Type
Experimental
Arm Title
Citrus flavonone-O-glycosides (High dose)
Arm Type
Experimental
Arm Title
Microcrystaline Cellulose- 400mg
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Citrus flavonone-O-glycosides- LD
Intervention Description
Low Dose of 200 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Citrus flavonone-O-glycosides- HD
Intervention Description
High Dose of 400 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (Microcrystalline Cellulose) of 400 mg
Primary Outcome Measure Information:
Title
Change in body fat percent Body Mass Index (kg/m2)
Description
Assessed using DEXA
Time Frame
16 weeks.
Title
Change in Lean Body Mass (g)
Description
Assessed using DEXA
Time Frame
16 weeks
Title
Change in Body Fat (%)
Description
Assessed using DEXA
Time Frame
16 weeks
Title
Change in Fat Free Mass (g)
Description
Assessed using DEXA
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Reveal
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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