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

NCT ID: NCT03973086

Last Updated: 2021-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2020-09-18

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Citrus flavonone-O-glycosides (Low dose)

Group Type EXPERIMENTAL

Citrus flavonone-O-glycosides- LD

Intervention Type DIETARY_SUPPLEMENT

Low Dose of 200 mg

Citrus flavonone-O-glycosides (High dose)

Group Type EXPERIMENTAL

Citrus flavonone-O-glycosides- HD

Intervention Type DIETARY_SUPPLEMENT

High Dose of 400 mg

Microcrystaline Cellulose- 400mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (Microcrystalline Cellulose) of 400 mg

Interventions

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Citrus flavonone-O-glycosides- LD

Low Dose of 200 mg

Intervention Type DIETARY_SUPPLEMENT

Citrus flavonone-O-glycosides- HD

High Dose of 400 mg

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (Microcrystalline Cellulose) of 400 mg

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Reveal

Bradenton, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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HP/190201/CITRUSLIM/BCMH

Identifier Type: -

Identifier Source: org_study_id

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