Back to resultsProduction of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles (METAc)
Primary Purpose
Obesity, Abdominal, Diabete Type 2
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nutritionnal intervention
Sponsored by
About this trial
This is an interventional basic science trial for Obesity, Abdominal focused on measuring Gut Microbiome, Endocannabinoidome, Metabolites, Microbiome-Endocannabinoidome Axis, Obesity, Type 2 Diabetes, Nutrition, Fatty Acids
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Institut sur la nutrition et les aliments fonctionnels - INAF
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05917132
Brief Title
Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles
Acronym
METAc
Official Title
Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 12, 2023 (Anticipated)
Primary Completion Date
June 12, 2024 (Anticipated)
Study Completion Date
June 12, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Diabete Type 2
Keywords
Gut Microbiome, Endocannabinoidome, Metabolites, Microbiome-Endocannabinoidome Axis, Obesity, Type 2 Diabetes, Nutrition, Fatty Acids
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nutritionnal intervention
Intervention Description
Participants will be provided with meals corresponding to each diet during the week. Participants will be required to eat only the meals provided.
Primary Outcome Measure Information:
Title
Fasting and postprandial lipid metabolite production in response to dietary lipid intervention in abdominal obesity and type 2 diabetes
Description
Interindividual variations in the endocannabinoidome mediators levels following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Gut microbiota in response to a 2 day dietary lipid intervention in abdominal obesity and type 2 diabetes
Description
Interindividual variations in the gut microbiota composition following a 2-day SFA and UFA diet intervention according to abdominal adiposity and type 2 diabetes.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Veilleux, PhD
Phone
418 656-3527
Email
alain.veilleux@fsaa.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Veilleux, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut sur la nutrition et les aliments fonctionnels - INAF
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles
We'll reach out to this number within 24 hrs