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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Citrus flavonone-O-glycosides- LD; Dietary Supplement: Citrus flavonone-O-glycosides- HD; Dietary Supplement: Placebo

• Registration Number: NCT03973086
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-07
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-01
• Study Start: 2019-06-04
• Study First Posted: 2019-06-04
• Primary Completion: 2020-05-30
• Study Completion: 2020-09-18
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Citrus flavonone-O-glycosides (Low dose)	Citrus flavonone-O-glycosides- LD	-
Citrus flavonone-O-glycosides (High dose)	Citrus flavonone-O-glycosides- HD	-
Microcrystaline Cellulose- 400mg	Placebo	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Reveal; 🇺🇸 Bradenton, Florida, United States