Diet Interactions With Human Gut Microbiota. The Potential Role of Mediterranean Diet Adherence. DIAGRAM, a Pilot Study (DIAGRAM)

March 9, 2017 updated by: University Hospital, Clermont-Ferrand

Despite the strong evidence on health benefits of traditional MeD, not many studies have broadly and systematically been made for the potential role and relationship of the MeD in the composition of the gut microbiota.

Furthermore, little is known about the composition of the gut microbiota in individuals with defined dietary habits on the Mediterranean pattern.

This work is aiming at comparatively studying the gut microbiota of three different dietary oriented european populations. In particular, biological samples and related information will be collected from populations with high adherence to Mediterranean diet (MeD) in Crete - Greece and Molise region - Italy. These data will be comparatively assessed with those provided by a sample population with high adherence to Western diet in Auvergne - France.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All the participants will give freely their written informed consent before their selection in the study.

Information on demographics, anthropometrics, vital signs, relevant medical history and concomitant medication, dietary habits, usual dietary intake and nutritional supplements will be collected. Habitual physical activity will be performed using the short form of the IPAQ survey. All inclusion and exclusion criteria will be checked by the investigator or co-investigator.

All selected volunteers will be asked to maintain their usual dietary habits and continue their normal physical habits. All volunteers will complete a follow-up questionnaire to obtain information about any changes in medication use, disease etc.

All selected volunteers will collect one stool sample and will complete two 24h dietary recalls, and questionnaires related to digestive function and life style.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

european populations

Description

Inclusion Criteria:

  • Aged 40 to 60 years
  • Healthy (apparently free of diseases)
  • Moderately physically active
  • Habitually eating foods representative of their community (Cretan diet, Italian Mediterranean diet, French Auvergnat diet). The assessment of the consumption of such food will be based to a detailed dietary history retrieved by a nutrition specialist)

Exclusion Criteria:

  • Following any kind of treatment, notably antibiotics the last 3 months
  • Sedentary lifestyle
  • BMI <18.5 Kg/m2-or >27Kg/m2
  • Smokers
  • Excessive alcohol consumption (>3 glasses/d for men and >2 glasses/d for women)
  • To be frequent travelers, particularly to overseas destinations
  • Pregnant or women at lactation
  • Individual unable to give informed consent or refusing to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
european population
Other: dietary habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacterial species composition of the fecal microbiota
Time Frame: at day 1
at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta diversity of fecal microbiota
Time Frame: at day 1
at day 1
Core microbiota (Alpha and Beta diversity of samples)
Time Frame: at day 1
Taxonomic affiliation will be performed after clustering of sequences at 97% to bacterial/archaeal groups using referenced databases: GreenGenes-RDP. Alpha and Beta diversity of samples will be determined after normalization of sample size. Analyses will also determine the core microbiota of each Group.
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Neuromed IRCCS
Centre de Recherche en Nutrition Humaine d'Auvergne
Mediterranean Agronomic Institute of Chania (MAICh) - CIHEAM, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0278
  • 2016-A00421-49 (Other Identifier: 2016-A00421-49)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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