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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03973086
Enrollment
97
Registered
2019-06-04
Start date
2019-06-04
Completion date
2020-09-18
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

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.

Interventions

DIETARY_SUPPLEMENTCitrus flavonone-O-glycosides- LD

Low Dose of 200 mg

DIETARY_SUPPLEMENTCitrus flavonone-O-glycosides- HD

High Dose of 400 mg

DIETARY_SUPPLEMENTPlacebo

Placebo (Microcrystalline Cellulose) of 400 mg

Sponsors

Vedic Lifesciences Pvt. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in body fat percent Body Mass Index (kg/m2)16 weeks.Assessed using DEXA
Change in Lean Body Mass (g)16 weeksAssessed using DEXA
Change in Body Fat (%)16 weeksAssessed using DEXA
Change in Fat Free Mass (g)16 weeksAssessed using DEXA

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026