Status:
COMPLETED
Healthy Fat, Happy Microbiome (TAPIR), Proof-of-Concept Study
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Wageningen University and Research
Conditions:
Small Intestine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: The role of dietary lipids in host-microbiome research has for a long time been overlooked; as high lipid intake has been recently indicated to have the most pronounced effect on the small ...
Eligibility Criteria
Inclusion
- Adult male or female
- BMI 18.5-30 kg/m2
- Suitable veins for insertion of cannula
Exclusion
- Having a history of medical or surgical events that may either put the subject at risk because of participation in the study, or influence the results of the study, including diabetes mellitus, dyslipidemia, a swallowing disorder, gastrointestinal or liver disease, irritable bowel syndrome, sleeping apnea, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants; as determined by the medical supervisor;
- Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
- Use of antibiotics within 3 months of starting the study or planned during the study;
- Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA), as determined by medical supervisor;
- Use of pro- and prebiotic supplements within 4 weeks of starting the study;
- Planning or scheduled to undergo magnetic resonance imaging (MRI) at any time during the course of the study (the SIMBA Capsule is MR unsafe)
- Currently following a very low carbohydrate (ketogenic) diet;
- Having regularly less than 3 bowel movements per week (being constipated);
- Alcohol consumption \>21 glasses a week (women) or \>28 glasses a week (men);
- Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
- Not willing to give up blood donation during the study;
- Food allergies or intolerances for products that we use in the study;
- Current smokers;
- Current users of soft and/or hard drugs;
- Participation in another clinical trial at the same time;
- Being an employee of the Food, Health \& Consumer Research group of Wageningen Food \& Biobased Research or Human Nutrition and Health Department of Wageningen University.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06064266
Start Date
October 20 2023
End Date
December 22 2023
Last Update
November 8 2024
Active Locations (1)
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1
Wageningen University
Wageningen, Gelderland, Netherlands, 6708WE