A clinical trial to study the effect of supplementing prebiotic Fructooligosaccharide on the direct and indirect determinants of the obesity outcomes in young adults (25 â?? 35 years age).
Phase 3
Completed
- Registration Number
- CTRI/2016/02/006611
- Lead Sponsor
- Government of India Ministry of Science and Technology Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Target Population: Obese (Grade-I) young Adults with Moderate risk of
Co-morbidities
Obesity defined as: >25 â?? 29.9 BMI
Age: 25 â?? 35 yrs
Gender: Both (Male and Female)
Exclusion Criteria
Subjects having confirmed following disorders:
Diabetes Mellitus
Hypertension
Cardio Vascular Disorder
Thyroid Hormone Disorder
Valve Replacement Surgery
Gastric Surgery or perforation
Taking Steroid based Medication
Immunocompromised Subjects
Heavy Physical Activity
Undergoing any treatment for Obesity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight loss <br/ ><br>Timepoint: Time-points: 0 day, 1months, 2 month and 3 months <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Atherogenic Profile (TC, TG, HDL, LDL and VLDL)Timepoint: 0 day and 3 month;Change in the levels of Plasma Lipopolysaccharide (Endotoxin)Timepoint: 0 day and 3 months;Defecation ProfileTimepoint: Zero day, 1months, 2 month and 3 months;Gut Microflora (Bifidobacteria, Lactobacillus, Clostridium, <br/ ><br> Bacteroides) <br/ ><br>Timepoint: 0 day and 3 months;Hunger â?? Satiety ScaleTimepoint: Zero day, 1months, 2 month and 3 months;Reduced Calorie consumption (24 hr Dietary Recall for 3 consecutive days)Timepoint: Zero day, 1months, 2 month and 3 months