Study title
The role of whole-grain barley on human fecal microbiota and metaboloma
Template
Intervention/Observation study
title
The role of whole-grain barley on human fecal microbiota and metaboloma
description
The pilot study was carried out in accordance with the Helsinki Declaration (IV Adaptation) and the European Guidelines for Good Clinical Practice. As a pilot study, no sample size calculation was performed and a target of 30 participants was established. The protocol of the study was approved by the Ethical Committee of the Azienda Ospedaliero-Universitaria Consorziale Policlinico of Bari, Italy. Healthy volunteers were enrolled according to the following inclusion/exclusion criteria: (i) Inclusion criteria: Healthy people aged 28-57 years old; BMI ranged between 18.4 and 26.0; omnivorous diet; (ii) Exclusion criteria: Diabetes type 2; urine protein > 1g/24h; antibiotics and probiotics administration by 90 days before the enrollment; gastrointestinal, celiac, inflammatory systemic and chronic liver diseases; recent diagnosis of cancer; corticosteroid or immunosuppressive therapies; previous major acute cardiovascular pathologies (heart attack, cerebral ictus); hyperlipidemia; consume of alcohol; psychiatric diseases. Written consents were obtained from all volunteers. One group of Caucasian Healthy Subjects (HS) (15 female and 11 male), aged between 28 and 57 years, were enrolled in the study.
startDate
2014-02-01 00:00:00.0
Study type
Human Intervention
Principle Investigator
Maria De Angelis
Primary endpoint
Exploring the fecal microbiota and metabolome
Objectives
Effect of two monts daily intake (3g) of barley β-glucans on fecal microbiota and metabolome in healthy subjects.
Central conclusion
Barley β-glucans exert a modulation of the composition and the metabolic pathways of the intestinal microbiota
Main health-related outcome
modulating the composition and metabolic pathways of the intestinal microbiota and SCFA
Exclusion criteria
Subjects withgastro-intestinal disease, diabetes, cardiovascular diseases, hyperlipidemia, extreme dietary behaviors, and consume of alcohol, treatment with antibiotics and/or functional foods (probiotics and/or prebiotics) were excluded.
Inclusion criteria
Caucasian Healthy Subjects (HS) (15 female and 11 male), aged between 28 and 57 years.
Institute
Di.S.S.P.A. (University of Bari)
via Amendola 165/A
Collaborators involved
Departmento of Soil, Plant and Food Sciences (University of Bari); DETO, Nephrology Unit (University of Bari); Department of Agricultural anf Food Sciences (University of Bologna); Inter-dipartimental Centre of Industrial Agri-food Research (University of
Country (for multicentre study overall PI)
Italy
Funding body
Ministero dell’Istruzione, dell’Università e della Ricerca; Ministero dello Sviluppo Economico; Fondo Europeo di Sviluppo Regionale
Study weblink
http://aem.asm.org/content/early/2015/08/31/AEM.02507-15
Clinicaltrials.gov or similar number
NCT02710513
Was the study approved by an ethics committee?
Yes
Ethical approval number
1570/2014
Did the individuals providing data sign informed consent?
Yes
Description of "Start groups"
After a two-months run-in period in which each volunteer followed a Mediterranean-based free diet including a daily supply of 100 g of usual pasta, each volunteer was given a supply of pasta “Cuore Mio” Granoro (Pastificio Attilio Mastromauro Granoro s.r.l. - Corato BA – Italy) and was instructed to include a daily portion (100 g, dry weight) of functional pasta in their Mediterranean-based diet for two months.
Type of controls
Healthy subjects before diet intervention
Number of factors (for factorial designs only)
2
Total number of arms (Give number of distinct treatments in study)
1
Explanatory text (Give a textual account of the overall design leading to the total number of groups) or provide the study protocol.
Investigation of the fecal microbiota and metabolome of healthy subjects before and after two months of diet intervention based on recommended daily intake (3g) of barley β-glucans. Microbiota were analyzed by culture-dependent and culture-independent analysis and community-level catabolic profiles. Metabolome analysis were performed using aminoacid analyzer ang GC-MS/SPME.
Treatments (Number and types of foods, drugs or other treatments compared)
Diet intervention based on 100 g of wheat pasta enriched of barley β-glucans (3g) every day for two months.
Number of volunteers screened N(M:xx, F: xx)
30 (M: 13, F: 17)
Number of volunteers enrolled N(M:xx, F: xx)
26 (M: 11, F: 15)
Number of subjects (Male; Female)
26 (M: 11, F: 15)
Start of recruitment (Start year or date)
2014-02-01 00:00:00.0
End of recruitment (End year or date)
2014-03-01 00:00:00.0
