Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03080532
Acronym
DIAGRAM
Enrollment
60
Registered
2017-03-15
Start date
2016-05-31
Completion date
2017-09-30
Last updated
2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Gut Microbiota

Keywords

Microbiome, Mediterranean diet

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.

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.

Interventions

OTHERdietary habits

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Bacterial species composition of the fecal microbiotaat day 1

Secondary

MeasureTime frameDescription
Beta diversity of fecal microbiotaat day 1
Core microbiota (Alpha and Beta diversity of samples)at day 1Taxonomic 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.

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026