Effect of probiotic and omega-3 fatty acid on blood glucose and lipid levels and gut bacteria in overweight/ obese volunteers

Phase 3

Completed

• Conditions: Overweight/Obese, Non-diabetic, non-hypertensive,without any Gastrointestinal disorders

• Registration Number: CTRI/2012/08/002856
• Lead Sponsor: National Institute of Nutrition

Brief Summary

This is a randomized, open-labeled, 4-arm arm trial to study the effects of supplementation with a probiotic preparation, VSL#3 and/or omega-3-fatty acids in healthy obese volunteers to look out for changes in serum inflammatory markers (TNF-alpha, IL-6, CRP, IL-1 Beta), lipid profile (Total cholesterol, HDl, LDL, VLDL, triglycerides), insulin sensitivity (Insulin resistance by HOMA-IR) and gut flora (fecal samples processed for quantification of bacterial strains by RT-PCR). The study Period is for 6 months from the recruitments and additional 2 months for data management and analysis. The volunteers would be screened and the study population will comprise of 60 cases. They would be randomized to 4 arms, namely, placebo, VSL#3, omega-3-fatty acids and VSL#3 + omega-3-fatty acids and provided with drugs for 6 weeks. Baseline characteristics and study related parameters would be assessed at baseline and after treatment of 45 days.

Specific probiotic strains improve intestinal barrier function, and may potentially diminish the translocation of micro-organisms and their derivatives, for example, lipopolysaccharide (LPS), from the gut to the systemic circulation, thereby reducing the concomitant release of pro-inflammatory cytokines via Toll-like receptor (TLR)-4 signalling. VSL#3 – a probiotic preparation contains 8 different strains of bacteria will be investigated to test its effects on insulin resistance, lipid profile, inflammation and gut microflora. Synergistic effect of VSL#3 and omega-3 fatty acid, a known anti-inflammatory nutrient, will also be investigated. Thus  a study will be undertaken with the following objectives.

1. To evaluate the effect of *VSL#3* on insulin sensitivity and inflammation in overweight and obese subjects.

2. To evaluate the synergistic impact of *VSL#3* and omega-3 fatty acid on insulin sensitivity and inflammation in overweight and obese subjects.

3. To determine the effect of VSL#3 on gut bacteria modulation and colonization ability of specific strains of VSL# 3.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-08
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age: 40-60 Yrs; Both male and female; Overweight subjects (BMI > 25) etc.

Exclusion Criteria

Hypertension; Diabetes Mellitus; Any metabolic disorder; GI disorders; Alcohol consumption; Smoking; antibiotic therapy etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of VSL#3 and omega-3 fatty acids on inflammatory markers, lipid profile characteristics, insulin sensitivity and gut flora.	6 weeks

Trial Locations

Locations (1)

Dept. of Microbiology and Immunology, Clinical Division, National Institute of Nutrition; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Dept. of Microbiology and Immunology, Clinical Division, National Institute of Nutrition

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr R Hemalatha

Principal investigator

040-27197297

rhemalathanin@yahoo.com