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

Vedic Lifesciences

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Citrus flavonone-O-glycosides- LD; Dietary Supplement: Placebo; Dietary Supplement: Citrus flavonone-O-glycosides- HD

Study type: Interventional

Funder types: Industry

Identifiers

NCT03973086

HP/190201/CITRUSLIM/BCMH

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

Citrus flavonone-O-glycosides (Low dose)

Experimental group

Treatment:

Dietary Supplement: Citrus flavonone-O-glycosides- LD

Citrus flavonone-O-glycosides (High dose)

Experimental group

Treatment:

Dietary Supplement: Citrus flavonone-O-glycosides- HD

Microcrystaline Cellulose- 400mg

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo