Clinical trial of Beach Body Gummies (BBG) in weight management.
- Conditions
- Health Condition 1: E669- Obesity, unspecified
- Registration Number
- CTRI/2023/05/052235
- Lead Sponsor
- Aesthetic Nutrition Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Obese patients (male/female and aged between 20-45 yrs. both inclusive);
2. BMI between 30 - 40 kg/m2;
3. Subjects with or without comorbidities, if comorbidity exists should be
on stable prescription and with following criteria- hypertension (Less than or equal to 140/90 mmHg on prescription), type 2 DM (HbA1C Less than or equal to 7.5 on prescription);
4. Willing to provide consent;
5. Willing for follow up
1. Subjects with any acute illness requiring immediate medical care;
2. Subjects with type I DM/complicated cardiovascular diseases / HbA1C more than
7.5. / history of TIA, cerebrovascular accident, stroke or any revascularization;
3. Known subjects of hepatic/renal failure;
4. Pregnant, breast feeding or planning to become pregnant during the study;
5. Any other condition which proves subject unfit for the study participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Changes in body weight from screening to end of the study. <br/ ><br>2. Changes in BMI from screening to end of the study. <br/ ><br>3. Changes in anthropometric parameters such as waist & hip circumference and body fat %, visceral fat % by bioelectrical impedance analysis (BIA) at screening and end of the study.Timepoint: Screening Day ,Baseline Day, Day 30(visit 1), Day 60(visit 2), Day 90(visit 3)
- Secondary Outcome Measures
Name Time Method 1. Changes in quality of life of subjects by modified IWQOL-Lite score at screening and end of the study. <br/ ><br>2. Changes in insulin resistance calculated as HOMA-IR score at screening <br/ ><br>and end of the study. <br/ ><br>3. Changes in lipid profile at screening and end of the study. <br/ ><br>4. Changes in general complaints like profuse sweating, irregular thirst, <br/ ><br>dyspnea and uncontrolled hunger on 0-10 VAS score from screening to end of the study.Timepoint: Screening Day ,Baseline Day, Day 30(visit 1), Day 60(visit 2), Day 90(visit 3)