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
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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COMPLETED
NA
97 participants
INTERVENTIONAL
2019-06-04
2020-09-18
Brief Summary
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This study focuses to prove the efficacy and safety of the product in a population of overweight and obese individual.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Citrus flavonone-O-glycosides (Low dose)
Citrus flavonone-O-glycosides- LD
Low Dose of 200 mg
Citrus flavonone-O-glycosides (High dose)
Citrus flavonone-O-glycosides- HD
High Dose of 400 mg
Microcrystaline Cellulose- 400mg
Placebo
Placebo (Microcrystalline Cellulose) of 400 mg
Interventions
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Citrus flavonone-O-glycosides- LD
Low Dose of 200 mg
Citrus flavonone-O-glycosides- HD
High Dose of 400 mg
Placebo
Placebo (Microcrystalline Cellulose) of 400 mg
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
60 Years
ALL
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Reveal
Bradenton, Florida, United States
Countries
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Other Identifiers
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HP/190201/CITRUSLIM/BCMH
Identifier Type: -
Identifier Source: org_study_id
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