- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03973086
To Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
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
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Bradenton, Florida, United States, 34205
- Reveal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
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)
|
Low Dose of 200 mg
|
Experimental: Citrus flavonone-O-glycosides (High dose)
|
High Dose of 400 mg
|
Placebo Comparator: Microcrystaline Cellulose- 400mg
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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