title: Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Open label, randomized, multicenter study.
  
  
  METHODS
  High-sensitivity C-reactive protein.
  
  
  METHODS
  Community.
  
  
  METHODS
  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.
  
  
  METHODS
  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.affiliation: Dept Gastroenterology and Hepatology, Charité-Universitätsmedizin Berlin, CCM, Charitéplatz 1, 10117 Berlin, Germany. Electronic address: valentini@hs-nb.de.
authors.forename: Luzia
authors.initials: L
authors.lastname: Valentini
authors.affiliation: Experimental Medicine Department, Sapienza University of Rome, P.le Aldo Moro 5, 00185 Rome, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pinto
authors.affiliation: CHU Bordeaux, Clinical Gerontology, France; CNRS, RMSB, UMR 5536, France; University Bordeaux, RMSB, UMR 5536, Bordeaux, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Bourdel-Marchasson
authors.affiliation: Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Via S. Giacomo 12, 40126 Bologna, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Ostan
authors.affiliation: Department of Pharmacy and Biotechnology, University of Bologna, Via Belmeloro 6, 40126 Bologna, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Brigidi
authors.affiliation: Department of Pharmacy and Biotechnology, University of Bologna, Via Belmeloro 6, 40126 Bologna, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Turroni
authors.affiliation: Dept Life Quality Studies, Alma Mater Studiorum University of Bologna, Via Irnerio 48, 40126 Bologna, Italy.
authors.forename: Silvana
authors.initials: S
authors.lastname: Hrelia
authors.affiliation: Department of Pharmacy and Biotechnology, University of Bologna, Via Belmeloro 6, 40126 Bologna, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Hrelia
authors.affiliation: Dept Microbiology and Hygiene, Charité-Universitätsmedizin Berlin, CBF, Hindenburgdamm 27, 12203 Berlin, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Bereswill
authors.affiliation: Dept Microbiology and Hygiene, Charité-Universitätsmedizin Berlin, CBF, Hindenburgdamm 27, 12203 Berlin, Germany.
authors.forename: André
authors.initials: A
authors.lastname: Fischer
authors.affiliation: Dept Life Quality Studies, Alma Mater Studiorum University of Bologna, Via Irnerio 48, 40126 Bologna, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Leoncini
authors.affiliation: Dept Life Quality Studies, Alma Mater Studiorum University of Bologna, Via Irnerio 48, 40126 Bologna, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Malaguti
authors.affiliation: CHU Bordeaux, Clinical Gerontology, 33000 Bordeaux, France.
authors.forename: Christéle
authors.initials: C
authors.lastname: Blanc-Bisson
authors.affiliation: CHU Bordeaux, Clinical Gerontology, 33000 Bordeaux, France.
authors.forename: Jessica
authors.initials: J
authors.lastname: Durrieu
authors.affiliation: Biostatistical Center INRCA, Via S. Margherita 5, 60100 Ancona, Italy.
authors.forename: Liana
authors.initials: L
authors.lastname: Spazzafumo
authors.affiliation: R&D, VoxNet CEO, Via Giovanni Paisiello 32, 00198 Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Buccolini
authors.affiliation: Actial Farmaceutica Lda, Praca Severiano Ferraz 258, 09000 082 Funchal, Portugal.
authors.forename: Florence
authors.initials: F
authors.lastname: Pryen
authors.affiliation: Experimental Medicine Department, Sapienza University of Rome, P.le Aldo Moro 5, 00185 Rome, Italy.
authors.forename: Lorenzo Maria
authors.initials: LM
authors.lastname: Donini
authors.affiliation: Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Via S. Giacomo 12, 40126 Bologna, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Franceschi
authors.affiliation: Experimental Medicine Department, Sapienza University of Rome, P.le Aldo Moro 5, 00185 Rome, Italy; Medical University of Innsbruck, Innrain 52, 6020 Innsbruck, Austria.
authors.forename: Herbert
authors.initials: H
authors.lastname: Lochs
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001688:Biological Products / Q000378:metabolism; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D002784:Cholesterol / Q000097:blood; D004032:Diet; D019587:Dietary Supplements; D005247:Feeding Behavior; D005260:Female; D005492:Folic Acid / Q000097:blood; D000069196:Gastrointestinal Microbiome; D006710:Homocysteine / Q000097:blood; D006801:Humans; D007249:Inflammation / Q000628:therapy*; D007422:Intestines / Q000382:microbiology*; D007778:Lactobacillus / Q000378:metabolism; D048668:Lactobacillus delbrueckii / Q000378:metabolism; D048191:Lactiplantibacillus plantarum / Q000378:metabolism; D008297:Male; D018384:Oxidative Stress / Q000502:physiology; D019936:Probiotics / Q000008:administration & dosage*; D048249:Streptococcus thermophilus / Q000378:metabolism; D014805:Vitamin B 12 / Q000097:blood
chemical_list: D001688:Biological Products; D015415:Biomarkers; D001786:Blood Glucose; D006710:Homocysteine; C010546:bifidobacterin; D002097:C-Reactive Protein; D005492:Folic Acid; D002784:Cholesterol; D014805:Vitamin B 12
keywords: Aging; Inflammation; Internet; Nutritional software; Oxidative stress; VSL#3