Food HabitsMETANCT03783260
Investigation of Microbiome-Derived Metabolite Production in Response to a Mediterranean Diet
A study testing Mediterranean diet in people with Food Habits, run by Laval University at 1 site in Canada.
Trial summary
This project proposes to characterise the microbiome-derived metabolites produced upon ingestion of bioactive precursor-rich meals by healthy volunteers in order to investigate the relationship between gut microbiome composition and the nature of dietary metabolites production. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Habits
- What is being tested?
- Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jan 2019to 1 Dec 2019
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged between 18 and 35 years
- Body mass index between 18.5 and 30 kg/m2
- General good health
- Computer and Internet access
- Basic understanding of written French
Who cannot join
- Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers
- Pregnant and/or breast-feeding women
- Alcohol consumption greater than 15 portions for men and 10 for women weekly
- Active tobacco usage
- Consumption of dietary supplements (e.g. multivitamins, omega-3, probiotics)
- Completion of a course of antibiotics in the past 3 months
Show all 9Show fewer
- Regular use of anti-inflammatory drugs, or use in the past 3 months
- Important weight change (+/- 5 kg) in the past 6 months
- Allergies or food intolerances to ingredients present in trial diets
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut sur la nutrition et les aliments fonctionnels - INAF
Québec, Quebec, G1V 0A6
About this study
This project proposes to characterise the microbiome-derived metabolites produced upon ingestion of bioactive precursor-rich meals by healthy volunteers in order to investigate the relationship between gut microbiome composition and the nature of dietary metabolites production.
Read the detailed description
There is a large inter-individual variability in gut microbiome-derived metabolites production upon ingestion of similar meals. Since many of these microbiome-derived metabolites have enteric and systemic biological effects, these variabilities could in part account for the different responses to meals and diets.
This project thus aims to improve the understanding the relationship between gut microbiome composition and the nature of dietary metabolites produced from similar bioactive precursor-rich meals.
The investigators therefore propose to characterise the circulating microbiome-derived metabolite profiles in healthy individuals fed the same 2-day precursor-rich Mediterranean diet prior to and after a 2-week of habitual Canadian diet feeding.
- Conditions
- Food Habits
- Being tested
- Mediterranean diet
- Keywords
- Gut Microbiome, Metabolites, Endocannabinoid, Mediterranean diet
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
During both Mediterranean diet periods, participants will be provided with meals and snacks representative of the Mediterranean nutritional habits. Participants will be required to eat only the meals provided.
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | All participating subjects will undergo two, 2-day Mediterranean diet feeding periods separated by a 14-day period of Canadian diet Receives: Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome-derived metabolite profiling
Plasma and urine metabolomics profiling of gut-microbiome derived metabolites (e.g., branched-chain amino acids [BCAA], short chain fatty acids [SCFA], trimethylamine [TMA], amino acids- and polyphenol-metabolites) will also performed at the same time points.
Measured: 19 days
Gut microbiome characterisation
Fecal microbiome composition will be characterise by rRNA 16S sequencing prior to and following both 2-day Mediterranean diet periods. Relevant indexes of microbiome diversity (e.g. Shannon beta-diversity), ratios between meaningful bacterial markers of gut dysbiosis (e.g. Firmicutes:Bacteroidetes) and specific microbiome differences in bacterial Families, Genera or species between study periods and individuals.
Measured: 19 days
Secondary outcomes (1)
Endocannabinoid interaction with interindividual microbiome composition
Interindividual variations in the endocannabinoid levels following a 2-day Mediterranean diet intervention according to individual gut microbiome composition will also be characterised. N-acyl ethanolamines, acylglycerols and omega-3 derived endocannabinoids will be quantified by LC MS-MS in plasma and urine samples collected prior to and following both 2-day Mediterranean diet periods.
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start7 Jan 2019
- Primary completion1 Apr 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HabitsStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Veilleux, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783260
- Sponsor's protocol ID
- 2018-262
- Acronym
- META
- Status last verified
- Feb 2020
- First submitted
- 12 Dec 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Microbiome-Derived Metabolite Production in Response to a Mediterranean Diet
- ClinicalTrials.gov ID
- NCT03783260
- Acronym / sponsor ID
- META / 2018-262
- Conditions
- Food Habits
- Keywords
- Gut Microbiome, Metabolites, Endocannabinoid, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 21 Dec 2018 (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.
This project proposes to characterise the microbiome-derived metabolites produced upon ingestion of bioactive precursor-rich meals by healthy volunteers in order to investigate the relationship between gut microbiome composition and the nature of dietary metabolites production.
Detailed description
There is a large inter-individual variability in gut microbiome-derived metabolites production upon ingestion of similar meals. Since many of these microbiome-derived metabolites have enteric and systemic biological effects, these variabilities could in part account for the different responses to meals and diets.
This project thus aims to improve the understanding the relationship between gut microbiome composition and the nature of dietary metabolites produced from similar bioactive precursor-rich meals.
The investigators therefore propose to characterise the circulating microbiome-derived metabolite profiles in healthy individuals fed the same 2-day precursor-rich Mediterranean diet prior to and after a 2-week of habitual Canadian diet feeding.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Other: Mediterranean dietAll participating subjects will undergo two, 2-day Mediterranean diet feeding periods separated by a 14-day period of Canadian diet |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged between 18 and 35 years
- Body mass index between 18.5 and 30 kg/m2
- General good health
- Computer and Internet access
- Basic understanding of written French
Key exclusion criteria (9 listed)
- Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers
- Pregnant and/or breast-feeding women
- Alcohol consumption greater than 15 portions for men and 10 for women weekly
- Active tobacco usage
- Consumption of dietary supplements (e.g. multivitamins, omega-3, probiotics)
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 |
|---|---|---|
| Mediterranean dietDuring both Mediterranean diet periods, participants will be provided with meals and snacks representative of the Mediterranean nutritional habits. Participants will be required to eat only the meals provided. | Other | Single |
Primary outcome
Microbiome-derived metabolite profiling
Time frame: 19 days
Plasma and urine metabolomics profiling of gut-microbiome derived metabolites (e.g., branched-chain amino acids [BCAA], short chain fatty acids [SCFA], trimethylamine [TMA], amino acids- and polyphenol-metabolites) will also performed at the same time points.
Gut microbiome characterisation
Time frame: 19 days
Fecal microbiome composition will be characterise by rRNA 16S sequencing prior to and following both 2-day Mediterranean diet periods. Relevant indexes of microbiome diversity (e.g. Shannon beta-diversity), ratios between meaningful bacterial markers of gut dysbiosis (e.g. Firmicutes:Bacteroidetes) and specific microbiome differences in bacterial Families, Genera or species between study periods and individuals.
1 secondary outcome
Endocannabinoid interaction with interindividual microbiome composition
Time frame: 19 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet in people with Food Habits, run by Laval University at 1 site in Canada.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 28 Feb 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome-derived metabolite profiling (time frame: 19 days). The study lists 2 primary outcomes in all. 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 28 Feb 2020.