Microbiota based personalized nutrition improves hyperglycaemia and hypertension parameters and reduces inflammation: a prospective, open label, controlled, randomized, comparative, proof of concept study.

Background: Recent studies suggest that gut microbiota composition, abundance and diversity can influence many chronic diseases such as type 2 diabetes. Modulating gut microbiota through targeted nutrition can provide beneficial effects leading to the concept of personalized nutrition for health improvement. In this prospective clinical trial, we evaluated the impact of a microbiome-based targeted personalized diet on hyperglycaemic and hyperlipidaemic individuals. Specifically, BugSpeaks®-a microbiome profile test that profiles microbiota using next generation sequencing and provides personalized nutritional recommendation based on the individual microbiota profile was evaluated. Methods: A total of 30 participants with type 2 diabetes and hyperlipidaemia were recruited for this study. The microbiome profile of the 15 participants (test arm) was evaluated using whole genome shotgun metagenomics and personalized nutritional recommendations based on their microbiota profile were provided. The remaining 15 participants (control arm) were provided with diabetic nutritional guidance for 3 months. Clinical and anthropometric parameters such as HbA1c, systolic/diastolic pressure, c-reactive protein levels and microbiota composition were measured and compared during the study. Results: The test arm (microbiome-based nutrition) showed a statistically significant decrease in HbA1c level from 8.30 (95% confidence interval (CI), [7.74-8.85]) to 6.67 (95% CI [6.2-7.05]), p < 0.001 after 90 days. The test arm also showed a 5% decline in the systolic pressure whereas the control arm showed a 7% increase. Incidentally, a sub-cohort of the test arm of patients with >130 mm Hg systolic pressure showed a statistically significant decrease of systolic pressure by 14%. Interestingly, CRP level was also found to drop by 19.5%. Alpha diversity measures showed a significant increase in Shannon diversity measure (p < 0.05), after the microbiome-based personalized dietary intervention. The intervention led to a minimum two-fold (Log2 fold change increase in species like Phascolarctobacterium succinatutens, Bifidobacterium angulatum, and Levilactobacillus brevis which might have a beneficial role in the current context and a similar decrease in species like Alistipes finegoldii, and Sutterella faecalis which have been earlier shown to have some negative effects in the host. Overall, the study indicated a net positive impact of the microbiota based personalized dietary regime on the gut microbiome and correlated clinical parameters.

Acarbose improves glycemic control as add-on or monotherapy in Indian type-2 diabetes: Findings from the GlucoVIP multinational observational study.

OBJECTIVE: To investigate the efficacy and tolerability of the anti-diabetic agent acarbose (Glucobay(®)) as add-on or monotherapy in a range of patients with type-2 diabetes mellitus (T2DM), including those with cardiovascular morbidities in India. MATERIALS AND METHODS: This was a part of a prospective, non-interventional, non-controlled, multicentre, multinational, observational study. The study included patients of either gender if they were aged at least 18 years and had untreated or pre-treated type-2 diabetes mellitus (T2DM) or impaired glucose tolerance and no acarbose treatment within the 3 months before study inclusion. RESULTS: In total, 1996 Indian patients were included in the effectiveness and 2010 in the safety analysis. Patients received acarbose (25-150 mg/day). The mean age of the patients was 50.1 years and the mean BMI was 27.2 kg/m(2). Mean 2-h post-prandial plasma glucose (PPG) value and fasting blood glucose (FBG) decreased from 243.9 to 169.5 mg/dl and 158.3 to 120.4 mg/dl, respectively after the last follow-up of 12.4 weeks. The mean HbA1c value at initial visit was 8.4% and was 7.4% at the last follow-up visit. FBG, PPG and HbA1c deceased in 90.6%, 94.4% and 52.4% patients respectively, by the last follow-up visit. The mean decrease in weight and waist circumference was 1.4 kg and 1.6 cm, respectively by the last follow-up visit. Physicians assessed the efficacy of drug as positive response in "very good to good" in 91.08%, "sufficient" in 7.92% and "insufficient" in 0.90% of patients. Also, continuation of Acarbose was reported in 97.09% of patients. Adverse events were reported in 2.74% and drug-related adverse events were reported in 2.19% of patients. Majority of them were gastrointestinal adverse events but were not serious. CONCLUSION: Acarbose is effective and safe in Indian patients with T2DM. Further, it helps in weight reduction and has very good compliance in patients with T2DM.