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CompletedNCT03973086Updated Apr 12, 2021

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

An interventional study of Citrus flavonone-O-glycosides- LD and Citrus flavonone-O-glycosides- HD in Overweight and Obesity, sponsored by Vedic Lifesciences Pvt. Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-12.

Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight and Obesity

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 97 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    Citrus flavonone-O-glycosides (Low dose)

    Dietary Supplement: Citrus flavonone-O-glycosides- LD

  • Experimental
    Citrus flavonone-O-glycosides (High dose)

    Dietary Supplement: Citrus flavonone-O-glycosides- HD

  • Placebo comparator
    Microcrystaline Cellulose- 400mg

    Dietary Supplement: Placebo

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

06

What researchers measure

Primary outcomes

  1. Change in body fat percent Body Mass Index (kg/m2)

    Assessed using DEXA

    Time frame: 16 weeks.

  2. Change in Lean Body Mass (g)

    Assessed using DEXA

    Time frame: 16 weeks

  3. Change in Body Fat (%)

    Assessed using DEXA

    Time frame: 16 weeks

  4. Change in Fat Free Mass (g)

    Assessed using DEXA

    Time frame: 16 weeks

07

Study locations

1 site
  • Reveal
    Bradenton, Florida 34205, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03973086
Lead sponsor
Vedic Lifesciences Pvt. Ltd.
Responsible party
Sponsor
First posted
Jun 4, 2019
Start date
Jun 4, 2019
Primary completion
May 30, 2020
Completion
Sep 18, 2020
Last update
Apr 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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