Luzia Valentini1, Alessandro Pinto2, Isabelle Bourdel-Marchasson3, Rita Ostan4, Patrizia Brigidi5, Silvia Turroni5, Silvana Hrelia6, Patrizia Hrelia5, Stefan Bereswill7, André Fischer7, Emanuela Leoncini6, Marco Malaguti6, Christéle Blanc-Bisson8, Jessica Durrieu8, Liana Spazzafumo9, Fabio Buccolini10, Florence Pryen11, Lorenzo Maria Donini2, Claudio Franceschi4, Herbert Lochs12. 1. Dept Gastroenterology and Hepatology, Charité-Universitätsmedizin Berlin, CCM, Charitéplatz 1, 10117 Berlin, Germany. Electronic address: valentini@hs-nb.de. 2. Experimental Medicine Department, Sapienza University of Rome, P.le Aldo Moro 5, 00185 Rome, Italy. 3. CHU Bordeaux, Clinical Gerontology, France; CNRS, RMSB, UMR 5536, France; University Bordeaux, RMSB, UMR 5536, Bordeaux, France. 4. Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Via S. Giacomo 12, 40126 Bologna, Italy. 5. Department of Pharmacy and Biotechnology, University of Bologna, Via Belmeloro 6, 40126 Bologna, Italy. 6. Dept Life Quality Studies, Alma Mater Studiorum University of Bologna, Via Irnerio 48, 40126 Bologna, Italy. 7. Dept Microbiology and Hygiene, Charité-Universitätsmedizin Berlin, CBF, Hindenburgdamm 27, 12203 Berlin, Germany. 8. CHU Bordeaux, Clinical Gerontology, 33000 Bordeaux, France. 9. Biostatistical Center INRCA, Via S. Margherita 5, 60100 Ancona, Italy. 10. R&D, VoxNet CEO, Via Giovanni Paisiello 32, 00198 Rome, Italy. 11. Actial Farmaceutica Lda, Praca Severiano Ferraz 258, 09000 082 Funchal, Portugal. 12. Experimental Medicine Department, Sapienza University of Rome, P.le Aldo Moro 5, 00185 Rome, Italy; Medical University of Innsbruck, Innrain 52, 6020 Innsbruck, Austria.
Abstract
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.
RCT Entities:
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.
Authors: C Custodero; R T Mankowski; S A Lee; Z Chen; S Wu; T M Manini; J Hincapie Echeverri; C Sabbà; D P Beavers; J A Cauley; M A Espeland; R A Fielding; S B Kritchevsky; C K Liu; M M McDermott; M E Miller; R P Tracy; A B Newman; W T Ambrosius; M Pahor; S D Anton Journal: Ageing Res Rev Date: 2018-05-25 Impact factor: 10.895
Authors: N Alihosseini; S A Moahboob; N Farrin; M Mobasseri; A Taghizadeh; A R Ostadrahimi Journal: Acta Endocrinol (Buchar) Date: 2017 Oct-Dec Impact factor: 0.877