Overweight and Obesity
Conditions
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.
Interventions
Low Dose of 200 mg
High Dose of 400 mg
Placebo (Microcrystalline Cellulose) of 400 mg
Sponsors
Study design
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States