Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53617
Enrollment
16
Registered
2023-08-01
Start date
2023-10-04
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vertering en microbioom digestion microbial fermentation

Interventions

8-days preconditioning mild ketogenic controlled diet followed by a high fat shake challenge with a naso-intestinal catheter.

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The primary study parameters are the microbial-derived metabolites from linoleic acid and plant sterols after consumption of the high fat shake.

Secondary

MeasureTime frame
Secondary study parameters include microbiota composition and transcriptomic activity. Other outcomes include inflammatory markers and ex-vivo analyses.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)