Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people.
Study Goal
The researchers aimed to determine whether adding VSL#3 to a personalized diet improved vitamin B12 levels and related biomarkers in healthy older adults, particularly those with low-grade inflammation.
Results Summary
The addition of VSL#3 significantly improved vitamin B12 plasma levels (p = 0.001) and reduced homocysteine (p < 0.001), with stronger effects observed in participants with baseline low-grade inflammation. The changes in vitamin B12 were positively correlated with increases in bifidobacteria.
Population
62 healthy persons aged 65-85 years, including subgroups with and without low-grade inflammation (hsCRP ≥3 mg/l vs. <3 mg/l).
Effective Dosage
2 capsules of VSL#3 per day (specific B12 dosage not specified).
Duration
8 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
personalized diet (RISTOMED diet) | decrease | ESR | 62 healthy persons aged 65-85 years | - | reduced | #1 |
personalized diet (RISTOMED diet) | decrease | plasma levels of cholesterol | 62 healthy persons aged 65-85 years | - | reduced | #2 |
personalized diet (RISTOMED diet) | decrease | plasma levels of glucose | 62 healthy persons aged 65-85 years | - | reduced | #3 |
VSL#3 supplementation | decrease | ESR | 62 healthy persons aged 65-85 years | - | reduced | #4 |
VSL#3 supplementation | increase | folate plasma levels | 62 healthy persons aged 65-85 years | - | improved | #5 |
VSL#3 supplementation | increase | vitamin B12 plasma levels | 62 healthy persons aged 65-85 years | - | improved | #6 |
VSL#3 supplementation | decrease | homocysteine plasma levels | 62 healthy persons aged 65-85 years | - | improved | #7 |
personalized diet (RISTOMED diet) | no change | inflammation | 62 healthy persons aged 65-85 years | - | demonstrated no further effects | #8 |
VSL#3 supplementation | no change | inflammation | 62 healthy persons aged 65-85 years | - | demonstrated no further effects | #9 |
VSL#3 supplementation | increase | bifidobacteria | 21 participants with low-grade inflammation at baseline (hsCRP≥3 mg/l, subgroup 2) | - | increased | #10 |
VSL#3 supplementation | increase | folate levels | 21 participants with low-grade inflammation at baseline (hsCRP≥3 mg/l, subgroup 2) | - | improved | #11 |
VSL#3 supplementation | increase | vitamin B12 levels | 21 participants with low-grade inflammation at baseline (hsCRP≥3 mg/l, subgroup 2) | - | improved | #12 |
VSL#3 supplementation | increase | bifidobacteria | 40 participants without signs of low-grade inflammation (hsCRP<3 mg/l, subgroup 1) | - | increased | #13 |
VSL#3 supplementation | increase | folate levels | 40 participants without signs of low-grade inflammation (hsCRP<3 mg/l, subgroup 1) | - | improved | #14 |
VSL#3 supplementation | increase | vitamin B12 levels | 40 participants without signs of low-grade inflammation (hsCRP<3 mg/l, subgroup 1) | - | improved | #15 |
VSL#3 supplementation | increase | bifidobacteria | subjects with low-grade inflammation | - | increased | #16 |
VSL#3 supplementation | increase | folate concentrations | subjects with low-grade inflammation | - | supported adequate | #17 |
VSL#3 supplementation | increase | vitamin B12 concentrations | subjects with low-grade inflammation | - | supported adequate | #18 |
VSL#3 supplementation | decrease | homocysteine | - | - | decrease | #19 |
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 65-85 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 = 0.02), plasma levels of cholesterol (p < 0.01) and glucose (p = 0.03). Addition of VSL#3 reduced ESR (p = 0.05) and improved folate (p = 0.007), vitamin B12 (p = 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 (hsCRP≥3 mg/l, subgroup 2). In subgroup 2 addition of VSL#3 increased bifidobacteria (p = 0.005) in more participants and improved both folate (p = 0.015) and vitamin B12 (p = 0.035) levels compared with subgroup 1. The increases were positively correlated to the change in the bifidobacteria concentration for folate (p = 0.023) and vitamin B12 (p = 0.001). As expected change in homocysteine correlated negatively to change in folate (r = -0.629, p = 0.002) and vitamin B12 (r = -0.482, p = 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: NCT01069445-NCT01179789.