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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Citrus flavonone-O-glycosides- LD
* Dietary Supplement: Citrus flavonone-O-glycosides- HD
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants with the age of ≥18 and ≤ 60 years of age. BMI of ≥25 - ≤ 35 kg/m2 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) Triglycerides >150 mg/dL Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg Fasting blood glucose ≥ 100 mg/ dl Low HDL level: Men: < 40 mg/dL, Women: < 50 mg/dL 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: Current smoker. Inability to walk independently. Presence of unstable, acutely symptomatic, or life-limiting illness. Neurological conditions causing functional or cognitive impairments Unwillingness or inability to be randomized to one of three intervention groups. Bilateral hip replacements. Exposure to any non-registered drug product within 3 months prior to the screening visit. Unable/unwillingness to complete study specific diaries (digital/paper-based).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citrus flavonone-O-glycosides (Low dose)<br> | Dietary Supplement: Citrus flavonone-O-glycosides- LD<br>* Low Dose of 200 mg<br>|
| Experimental: Citrus flavonone-O-glycosides (High dose)<br> | Dietary Supplement: Citrus flavonone-O-glycosides- HD<br>* High Dose of 400 mg<br>|
| Placebo Comparator: Microcrystaline Cellulose- 400mg<br> | Dietary Supplement: Placebo<br>* Placebo (Microcrystalline Cellulose) of 400 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body fat percent Body Mass Index (kg/m2) | Assessed using DEXA | 16 weeks. | 
| Change in Lean Body Mass (g) | Assessed using DEXA | 16 weeks | 
| Change in Body Fat (%) | Assessed using DEXA | 16 weeks | 
| Change in Fat Free Mass (g) | Assessed using DEXA | 16 weeks |