HealThy fAt, haPpy mIcRobiome - Proof-of-Concept Study

Completed

• Conditions: vertering en microbioom; digestion; microbial fermentation; 10013317

• Registration Number: NL-OMON53617
• Lead Sponsor: Wageningen Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

- Male or female adults
- BMI 18.5-30 kg/m2
- Suitable veins for insertion of cannula

Exclusion Criteria

- 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, a swallowing disorder,
gastrointestinal or liver disease, dyslipidemia, sleeping apnea, irritable
bowel syndrome, 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 medications known to interfere with gastro-intestinal function (e.g.
gastric acid inhibitors), 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 - Currently following a very low carbohydrate
(ketogenic) diet;
- 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;
- Having fewer than three bowel movements per week (having constipation)
- Being an employee of the Food, Health & Consumer Research group of Wageningen
Food & Biobased Research or Human Nutrition and Health Department of Wageningen
University.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are the microbial-derived metabolites from<br /><br>linoleic acid and plant sterols after consumption of the high fat shake. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include microbiota composition and transcriptomic<br /><br>activity. Other outcomes include inflammatory markers and ex-vivo analyses.</p><br>