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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973086
• Other study ID #: HP/190201/CITRUSLIM/BCMH
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: September 18, 2020

Study information

• Verified date: June 2019
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 18, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	Reveal	Bradenton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body fat percent Body Mass Index (kg/m2)	Assessed using DEXA	16 weeks.
Primary	Change in Lean Body Mass (g)	Assessed using DEXA	16 weeks
Primary	Change in Body Fat (%)	Assessed using DEXA	16 weeks
Primary	Change in Fat Free Mass (g)	Assessed using DEXA	16 weeks