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

• Sponsor: Vedic Lifesciences Pvt. Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03973086
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Arms: 3
• Actual Duration (Months): 15.5
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Dietary Supplement: Citrus flavonone-O-glycosides- LD; Dietary Supplement: Citrus flavonone-O-glycosides- HD; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jun 4, 2019
• Actual Primary Completion Date: May 30, 2020
• Actual Study Completion Date: Sep 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Citrus flavonone-O-glycosides (Low dose)	Dietary Supplement: Citrus flavonone-O-glycosides- LD; Low Dose of 200 mg
Experimental: Citrus flavonone-O-glycosides (High dose)	Dietary Supplement: Citrus flavonone-O-glycosides- HD; High Dose of 400 mg
Placebo Comparator: Microcrystaline Cellulose- 400mg	Dietary Supplement: Placebo; Placebo (Microcrystalline Cellulose) of 400 mg

Outcome Measures

Primary Outcome Measures

1. Change in body fat percent Body Mass Index (kg/m2) [16 weeks.]

   Assessed using DEXA

2. Change in Lean Body Mass (g) [16 weeks]

   Assessed using DEXA

3. Change in Body Fat (%) [16 weeks]

   Assessed using DEXA

4. Change in Fat Free Mass (g) [16 weeks]

   Assessed using DEXA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: 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:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reveal	Bradenton	Florida	United States	34205

Sponsors and Collaborators

• Vedic Lifesciences Pvt. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vedic Lifesciences Pvt. Ltd.
• ClinicalTrials.gov Identifier: NCT03973086
• Other Study ID Numbers: HP/190201/CITRUSLIM/BCMH
• First Posted: Jun 4, 2019
• Last Update Posted: Apr 12, 2021
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight; Cardiac Glycosides

Study Results

No Results Posted as of Apr 12, 2021