Obesity, AbdominalMETAcNCT05917132
Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles
A study testing Nutritionnal intervention in people with Obesity, Abdominal and Diabete Type 2, run by Laval University at 1 site in Canada.
Trial summary
The proposed project mainly aims to investigate the microbial processes leading to dietary metabolites production, independently of long-term microbiota adaptation to the diet, by measuring the microbiota-derived metabolite production from a meal sequence rich in saturated fatty acids (SFA) or the same meals but rich… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Diabete Type 2
- What is being tested?
- Nutritionnal intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2023to 1 Dec 2024
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 45 and 65 years, menopaused women ;
- Body mass index between 20 to 35 kg/m² ;
- General good health ;
- Score of diet quality (HEI) between 40 and 70 ;
- Computer and Internet access ;
- Basic understanding of written French ;
- Daily stool frequency.
Who cannot join
- Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers ;
- Alcohol consumption greater than 15 portions for men and 10 for women weekly.
- Active tobacco and cannabis usage ;
- Consumption of omega-3 dietary supplements ;
- Consumption of dietary supplements (vitamins and probiotics) - must be ceased 2 weeks before the dietary intervention ;
- Completion of a course of antibiotics in the past 3 months ;
- Important weight change (+/- 5 kg) in the past 6 months ;
- Type 1 diabetes or insulin-treated diabetes.
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
The proposed project mainly aims to investigate the microbial processes leading to dietary metabolites production, independently of long-term microbiota adaptation to the diet, by measuring the microbiota-derived metabolite production from a meal sequence rich in saturated fatty acids (SFA) or the same meals but rich in polyunsaturated fatty acids (PUFA) in individuals with or without obesity and Type 2 diabetes (T2D)
Read the detailed description
The gut microbiota interacts with the host's enteric and systemic functions through the production of gut microbiota-derived metabolites. A subset of these metabolites, the endocannabinoids (eCB) and their congeners are derived from fatty acids and play a crucial role in metabolic health.
The research project aims to study gut microbiota-derived metabolites, including the eCB and their congeners, in response to a 2-day diet rich in polyunsaturated fatty acids or rich in saturated fatty acids in individuals with or without abdominal obesity and type 2 diabetes.
The investigators hope to better understand the kinetic production of circulating endocannabinoidome mediators derived from fatty acids in the diet.
- Conditions
- Obesity, Abdominal, Diabete Type 2
- Being tested
- Nutritionnal intervention
- Keywords
- Gut Microbiome, Endocannabinoidome, Metabolites, Microbiome-Endocannabinoidome Axis, Obesity, Type 2 Diabetes, Nutrition, Fatty Acids
- Medical subject headings
- Obesity, Abdominal, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritionnal interventionOther
Participants will be provided with meals corresponding to each diet during the week. Participants will be required to eat only the meals provided.
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | All participating subjects will undergo 3 feeding phases : 3 days of a run-in diet, 2 days of a polyunsaturated fatty acid (PUFA) diet and 2 days of a saturated fatty acid (SFA) diet. Receives: Other: Nutritionnal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes
Interindividual variations in the endocannabinoidome mediators levels following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.
Measured: 7 days
Secondary outcomes (1)
Gut microbiota in response to a 2 day dietary lipid intervention in abdominal obesity and type 2 diabetes
Interindividual variations in the gut microbiota composition following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start12 Jun 2023
- Primary completion31 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Veilleux, Laval University
- Investigators
- Alain Veilleux, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917132
- Sponsor's protocol ID
- 2022-109
- Acronym
- METAc
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles
- ClinicalTrials.gov ID
- NCT05917132
- Acronym / sponsor ID
- METAc / 2022-109
- Conditions
- Obesity, Abdominal, Diabete Type 2
- Keywords
- Gut Microbiome, Endocannabinoidome, Metabolites, Microbiome-Endocannabinoidome Axis, Obesity, Type 2 Diabetes, Nutrition, Fatty Acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 Jun 2023 (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.
The proposed project mainly aims to investigate the microbial processes leading to dietary metabolites production, independently of long-term microbiota adaptation to the diet, by measuring the microbiota-derived metabolite production from a meal sequence rich in saturated fatty acids (SFA) or the same meals but rich in polyunsaturated fatty acids (PUFA) in individuals with or without obesity and Type 2 diabetes (T2D)
Detailed description
The gut microbiota interacts with the host's enteric and systemic functions through the production of gut microbiota-derived metabolites. A subset of these metabolites, the endocannabinoids (eCB) and their congeners are derived from fatty acids and play a crucial role in metabolic health.
The research project aims to study gut microbiota-derived metabolites, including the eCB and their congeners, in response to a 2-day diet rich in polyunsaturated fatty acids or rich in saturated fatty acids in individuals with or without abdominal obesity and type 2 diabetes.
The investigators hope to better understand the kinetic production of circulating endocannabinoidome mediators derived from fatty acids in the diet.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Other: Nutritionnal interventionAll participating subjects will undergo 3 feeding phases : 3 days of a run-in diet, 2 days of a polyunsaturated fatty acid (PUFA) diet and 2 days of a saturated fatty acid (SFA) diet. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged between 45 and 65 years, menopaused women ;
- Body mass index between 20 to 35 kg/m² ;
- General good health ;
- Score of diet quality (HEI) between 40 and 70 ;
- Computer and Internet access ;
Key exclusion criteria (8 listed)
- Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers ;
- Alcohol consumption greater than 15 portions for men and 10 for women weekly.
- Active tobacco and cannabis usage ;
- Consumption of omega-3 dietary supplements ;
- Consumption of dietary supplements (vitamins and probiotics) - must be ceased 2 weeks before the dietary intervention ;
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 |
|---|---|---|
| Nutritionnal interventionParticipants will be provided with meals corresponding to each diet during the week. Participants will be required to eat only the meals provided. | Other | Single |
Primary outcome
Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes
Time frame: 7 days
Interindividual variations in the endocannabinoidome mediators levels following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.
1 secondary outcome
Gut microbiota in response to a 2 day dietary lipid intervention in abdominal obesity and type 2 diabetes
Time frame: 7 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 27 Jun 2025.
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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.
Alain Veilleux, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritionnal intervention in people with Obesity, Abdominal and Diabete Type 2, 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 7 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: finished, as of the sponsor's last update on 27 Jun 2025. 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?
Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes (time frame: 7 days). 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 27 Jun 2025.