Human Gut MicrobiotaDIAGRAMNCT03080532
Diet Interactions With Human Gut Microbiota. The Potential Role of Mediterranean Diet Adherence. DIAGRAM, a Pilot Study
An observational study of Human Gut Microbiota, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Gut Microbiota
- What is being tested?
- dietary habits
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: european populations
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Ruddy RICHARD
About this study
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.
Read the 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.
- Conditions
- Human Gut Microbiota
- Being tested
- dietary habits
- Keywords
- Microbiome, Mediterranean diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary habitsOther
| Study group | Role | What they receive |
|---|---|---|
| european population | Not described Receives: Other: dietary habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial species composition of the fecal microbiota
Measured: at day 1
Secondary outcomes (2)
Beta diversity of fecal microbiota
Measured: at day 1
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.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startMay 2016
- Primary completionFeb 2017
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Gut MicrobiotaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Mediterranean Agronomic Institute of Chania (MAICh) - CIHEAM, Greece, Neuromed IRCCS
- Responsible party
- Sponsor
- Investigators
- Ruddy RICHARD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080532
- Sponsor's protocol ID
- CHU-0278
- Other IDs
- 2016-A00421-49
- Acronym
- DIAGRAM
- Status last verified
- Mar 2017
- First submitted
- 9 Sep 2016
- Last updated
- 15 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Interactions With Human Gut Microbiota. The Potential Role of Mediterranean Diet Adherence. DIAGRAM, a Pilot Study
- ClinicalTrials.gov ID
- NCT03080532
- Acronym / sponsor ID
- DIAGRAM / CHU-0278
- Conditions
- Human Gut Microbiota
- Keywords
- Microbiome, Mediterranean diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Mediterranean Agronomic Institute of Chania (MAICh) - CIHEAM, Greece, Neuromed IRCCS
- Study start
- May 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| european population | – | Other: dietary habits |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- european populations
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary habits | Other | european population |
Primary outcome
Bacterial species composition of the fecal microbiota
Time frame: at day 1
2 secondary outcomes
Beta diversity of fecal microbiota
Time frame: at day 1
Core microbiota (Alpha and Beta diversity of samples)
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Related trials for Human Gut Microbiota
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Not yet recruiting
AdHuman - Impact of Food Additives in Humans
Healthy Adult
Recruiting
Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
Physical Abilities, FMT
Not yet recruiting
High-Resolution Measurements of Diet-Microbiome Interactions
IBS (Irritable Bowel Syndrome)
Not yet recruiting
Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With Human Papillomavirus (HPV)
Human Papillomavirus Infection, Human Papillomavirus Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruddy RICHARD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Gut Microbiota, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial species composition of the fecal microbiota (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.