Microbiota and Related Metabolome in Omnivore, Vegetarian or Vegan Diets

NCT02118857 | Unknown

• 2 other identifiers: PRIN-2014-GBMG160102
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The human body houses a huge microbial ecosystem, including the intestinal and oral microbiota. Both these ecosystems, and, in particular, the intestinal one, are responsible for maintaining human health. The response of the organism to the diet and the relative alteration of the susceptibility to disease are worth of investigation to comprehend the role of the microbiota to maintain the state of well being in humans. This concept, which is the overall scientific basis of the entire project, perfectly fits with the declared scopes of Horizon 2020. Understanding the impact of omnivore, vegetarian and vegan diets on human intestinal microbiota is aligned to the Grand Societal Challenge of the Horizon 2020 scheme, which is addressing the human nutritional needs and the impact of food on human physiological functions. In particular, studying the link between dietary habits and the intestinal microbiota activity will be pivotal to improve the food-based promotion of health and well being. The project aims at studying how the omnivore, vegetarian and vegan diets may affect the oral intake of microorganims, and the composition of the oral and fecal microbiota. With the aim to build up a permanent European platform for such type of studies, ten Research Units (RUs) are involved in the proposal, with the partnership of 16 National and, especially, foreign Institutions, covering 12 different countries. About 50 omnivore, vegetarian and vegan volunteers, for a total of 150 subjects will be recruited. Volunteers will be asked to fill in diaries, describing their dietary habits, and to collect biological samples (saliva, feces and urine), once a week for three weeks. For obvious ethical constraints, biopsies will be not available in this study. RUs will share their tasks, mainly depending on the nature of the samples to be studied, namely foods and biological samples. Based on the different dietary habits, the presumptive intake of microorganims will be estimated using literature data and, especially, culture-dependent methods. Typing and antibiotic resistance of some food related microbial communities or foods will be also investigated. The microbial diversity of foods, whose microbiota has never been studied in depth, will be characterized by PCR-DGGE and deep sequencing. The metabolome characterization will complete the overview on foods. After collecting and preparing biological samples from the three diet groups, the oral and fecal microbiota will be studied. The viable cell number of several microbial groups will be estimated in fecal samples, before freezing. Preliminarily, the microbial diversity of saliva and fecal ecosystems will be analyzed through PCR-DGGE. PCR assessment of genetic basis of antibiotic resistance will be also carried out. Selected numbers of biological samples will be further subjected to next generation sequencing, aiming at determining representative individuals/samples of the three types of diet. Only for feces, representative samples (e.g., 4/5 for each diet) will be subjected to meta-omics analyses based on meta-genomic, meta-transcriptomic and meta-proteomic approaches. An integrated and iterative workflow will be also developed, by assembling an in house synthetic meta-genome. The functionality of fecal samples and/or of isolates from feces will be characterized based on fecal genotoxic and anti-genotoxic activities, and modulation of the immune response. In agreement with an holistic approach, the metabolome analysis of saliva, feces and urine will complete the characterization of biological samples. All data available from the different RUs will merge into a common database, whose structure will be developed during the project. Based on the literature data (ISI Web of Knowledge), this is the first study that aims at correlating the effect of the main dietary habits on the oral and fecal microbiota through integrated meta-omics analyses.

Conditions

Diet and Human Microbiota

Keywords

Microorganisms and foods; Fecal microbiota; Salivary microbiota

Outcome Measures

Primary Outcomes (1)

• Quantitative determination of microrganisms (cell density:Log CFU/g) in food and in biological samples (saliva, feces and urina) through culture independent approach on different selective culture media.

  Omnivore, vegetarian and vegan subjects followed the specific diet from at least two years.

  For 3 weeks from recruiting

Secondary Outcomes (1)

• Global analysis of microbial diversity (rarefaction maximum predicted (RFM), Chao and Shannon diversity index) from food and biological samples, and integrated meta-omics (metagenomics, metatranscriptomics, metaproteomics, metabolomics).

  For 3 weeks from recruiting.

Other Outcomes (1)

• Genotoxicity (Comet assay) and residual genotoxic activity of the compounds (SOS-Chromotest) from samples of fecal water (FW).

  For 3 weeks from recruiting.

Study Arms (1)

Omnivore, vegetarian and vegan subjects.

These subjecs followed the diet from at least two years.

Other: Omnivore, vegetarian and vegan subjects.

Interventions

Omnivore, vegetarian and vegan subjects. OTHER

Omnivore, vegetarian and vegan subjects collected the feces, urina and saliva samples for 3 weeks from recruiting.

Omnivore, vegetarian and vegan subjects.

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study focused on enrolling of 150 healthy volunteers including an equal number of omnivores, vegetarians and vegans (age 18-59 years, male/female ratio ca. 1:1). Recruited volunteers will be asked to sign a consensus document, to record their dietary habits and to collect biological samples (saliva, feces and urine).

You may qualify if:

• Age (18 - 59 years).
• BMI (18.5-24.9 kg/m2).
• No usual intake of drugs and dietary supplements / pharmacological pre-and probiotics.
• No taking antibiotics in the last three months.
• Absence of intestinal (Crohn's disease, ulcerative colitis, bacterial contamination syndrome, constipation, celiac disease, irritable bowel disease) and metabolic (diabetes type 1 and type 2, cardiovascular and neurovascular diseases, cancer, neurodegenerative diseases, rheumatoid arthritis, allergies) diseases.
• No pregnancy and breast-feeding.

You may not qualify if:

• Inability to give the informed consent.

Sponsors & Collaborators

• University of Bari: lead
• University Of Perugia: collaborator
• Federico II University: collaborator
• University of Parma: collaborator
• University of Teramo: collaborator
• University of Bologna: collaborator
• Università Politecnica delle Marche: collaborator
• University of Turin, Italy: collaborator
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator

Study Sites (2)

Università di Bari

Bari, Bari, 70126, Italy

RECRUITING

Università di Bari

Bari, Bari, 70126, Italy

RECRUITING

Related Publications (1)

• De Filippis F, Pellegrini N, Vannini L, Jeffery IB, La Storia A, Laghi L, Serrazanetti DI, Di Cagno R, Ferrocino I, Lazzi C, Turroni S, Cocolin L, Brigidi P, Neviani E, Gobbetti M, O'Toole PW, Ercolini D. High-level adherence to a Mediterranean diet beneficially impacts the gut microbiota and associated metabolome. Gut. 2016 Nov;65(11):1812-1821. doi: 10.1136/gutjnl-2015-309957. Epub 2015 Sep 28.

  PMID: 26416813 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Feces, urine and saliva samples

Study Officials

• Marco Gobbetti, Professor

  University of Bari

  STUDY CHAIR

Central Study Contacts

Marco Gobbetti, Professor

CONTACT

00390805442949; marco.gobbetti@uniba.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 21, 2014
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2016
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

IT (2)