Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people.

Objectives: To assess the impact of a personalized diet, with or without addition of VSL#3 preparation, on biomarkers of inflammation, nutrition, oxidative stress and intestinal microbiota in 62 healthy persons aged 65e85 years. Design: Open label, randomized, multicenter study. Primary endpoint: High-sensitivity C-reactive protein. Setting: Community. Interventions: Eight week web-based dietary advice (RISTOMED platform) alone or with supplementation of VSL#3 (2 capsules per day). The RISTOMED diet was optimized to reduce inflammation and oxidative stress. Measurements: Blood and stool samples were collected on days 1 and 56. Results: Diet alone reduced ESR (p ¼ 0.02), plasma levels of cholesterol (p < 0.01) and glucose (p ¼ 0.03). Addition of VSL#3 reduced ESR (p ¼ 0.05) and improved folate (p ¼ 0.007), vitamin B12 (p ¼ 0.001) and homocysteine (p < 0.001) plasma levels. Neither intervention demonstrated any further effects on inflammation. Subgroup analysis showed 40 participants without signs of low-grade inflammation (hsCRP<3 mg/l, subgroup 1) and 21 participants with low-grade inflammation at baseline (hsCRP3 mg/ l, subgroup 2). In subgroup 2 addition of VSL#3 increased bifidobacteria (p ¼ 0.005) in more participants and improved both folate (p ¼ 0.015) and vitamin B12 (p ¼ 0.035) levels compared with subgroup 1. The increases were positively correlated to the change in the bifidobacteria concentration for folate (p ¼ 0.023) and vitamin B12 (p ¼ 0.001). As expected change in homocysteine correlated negatively to change in folate (r ¼ 0.629, p ¼ 0.002) and vitamin B12 (r ¼ 0.482, p ¼ 0.026).Conclusions: Addition of VSL#3 increased bifidobacteria and supported adequate folate and vitamin B12 concentrations in subjects with low-grade inflammation. Decrease in homocysteine with VSL#3 was clinically relevant. suggesting protective potentials for aging-associated conditions, e.g. cardiovascular or neurological diseases. ClinicalTrials.gov: NCT01069445eNCT01179789.