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

NCT03080532 | Unknown

• 2 other identifiers: CHU-02782016-A00421-49
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Gut Microbiota

Keywords

Microbiome; Mediterranean diet

Outcome Measures

Primary Outcomes (1)

• Bacterial species composition of the fecal microbiota

  at day 1

Secondary Outcomes (2)

• Beta diversity of fecal microbiota

  at day 1

• Core microbiota (Alpha and Beta diversity of samples)

  at day 1

Study Arms (1)

european population

Other: dietary habits

Interventions

dietary habits OTHER

european population

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

european populations

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator
• Mediterranean Agronomic Institute of Chania (MAICh) - CIHEAM, Greece: collaborator
• Neuromed IRCCS: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Study Officials

• Ruddy RICHARD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: March 15, 2017
• Study Start: May 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

FR (1)