To study the Effectiveness of Oral Nutrition Supplement in Obese Population.â??
- Registration Number
- CTRI/2021/09/036636
- Lead Sponsor
- Signutra Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 107
oSubjects with abdominal obesity: Waist circumference >= 102 cm and >= 88 cm, in men and women, respectively and BMI >=30.0 kg/m2
oSubjects not capable of understanding the informed consent.
oSubjects who are on lipid lowering treatment with statins, fibrates, etc. with a known dose change over the latest 3 months (changes not allowed during the trial)
oPresence of metabolic chronic disease, including type 2 diabetes (HbA1c >6.5) or hypothyroidism.
oObesity secondary to other underlying diseases such as Cushingâ??s syndrome, hypothyroidism, etc.
oTreatment with corticosteroids as well as other drugs known to significantly influence body weight, such as GLP-1 agonists.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - To determine efficacy of Vidaslim® in weight loss among obese population. <br/ ><br>- To determine safety and compliance of Vidaslim® in weight loss among obese population.Timepoint: 0 8 16 weeks
- Secondary Outcome Measures
Name Time Method - To determine safety and compliance of Vidaslim® in weight loss among obese population.Timepoint: 0 8 16 weeks