A randomized controlled intervention study to determine the synergistic effect of probiotic and omega-3 fatty acid on lipid profile, insulin sensitivity, inflammatory markers and colonization ability on overweight/ obese volunteers

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.