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

Human Gut Microbiota Clinical Trial

— DIAGRAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03080532
• Other study ID #: CHU-0278
• Secondary ID: 2016-A00421-49
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2016
• Last updated: March 9, 2017
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Gut Microbiota

Intervention

Other:
• dietary habits

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre de Recherche en Nutrition Humaine d'Auvergne, Mediterranean Agronomic Institute of Chania (MAICh) – CIHEAM, Greece, Neuromed IRCCS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial species composition of the fecal microbiota		at day 1
Secondary	Beta diversity of fecal microbiota		at day 1
Secondary	Core microbiota (Alpha and Beta diversity of samples)	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