To assess the effect of dietary lipids on the small intestinal microbiome in humans (proof-of-concept), the primary objective is to measure production of microbiota-derived lipid metabolites in the human small intestine after consumption of a high-…
ID
Source
Brief title
Condition
- Other condition
- Lipid metabolism disorders
Synonym
Health condition
vertering en microbioom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the microbial-derived metabolites from
linoleic acid and plant sterols after consumption of the high fat shake.
Secondary outcome
Secondary study parameters include microbiota composition and transcriptomic
activity. Other outcomes include inflammatory markers and ex-vivo analyses.
Background summary
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 intestinal microbiome, hence fecal-oriented
studies might have missed their important, local effect. Many of the uniquely
formed metabolites still have to be accurately described, and even so their
biological function, including e.g. potential anti-obesity and immune effects,
remains to be elucidated. This study therefore aims at exploring this principal
in vivo in healthy individuals.
Study objective
To assess the effect of dietary lipids on the small intestinal microbiome in
humans (proof-of-concept), the primary objective is to measure production of
microbiota-derived lipid metabolites in the human small intestine after
consumption of a high-fat shake in healthy pre-conditioned subjects.
The secondary objectives are 1) To compare the microbiota-derived lipid
metabolites in aspirate samples obtained with a naso-intestinal catheter
(golden standard; invasive sampling method), and an aspiration capsule (less
invasive, innovative sampling method), and in blood (local versus systemic
effect) and feces (small intestinal versus fecal effect; less invasive
sampling); 2) To investigate the acute effect of a high-fat shake on the
composition and transcriptomic activity of the small intestine microbiota in
aspirate samples of healthy pre-conditioned subjects; 2a) To compare the acute
effects on the small intestine microbiota composition in aspirate samples
obtained through a naso-intestinal catheter versus those obtained via an
aspiration capsule; 3) To study and compare the effect of a plant-based mild
ketogenic preconditioning diet on the composition of the small intestinal
microbiota (aspiration capsule) and the fecal microbiota.
Study design
Proof-of-concept intervention study
Intervention
8-days preconditioning mild ketogenic controlled diet followed by a high fat
shake challenge with a naso-intestinal catheter.
Study burden and risks
This study is related to a broad general population. There are minor risks for
the healthy research subjects of this study. Placement of the naso-intestinal
catheter can result in discomfort. The radiation exposure during placement is
minimal (maximum 0.05-0.10 mSv) and induces a minimal health risk to the
healthy subjects. Consumption of the mild ketogenic diet and the liquid
high-fat shake may cause gastro-intestinal discomfort. Blood sampling will be
performed via a cannula and the insertion can be painful and may cause a
bruise. The amount of blood that is drawn from subjects is within acceptable
limits (total amount collected = 89mL). Research subjects will invest
approximately 22 hours in the study. They will visit the research facility 6
times: short screening, capsule and preconditioning diet pick-up,
naso-intestinal catheter insertion, high-fat shake challenge test day, and
fecal sample hand-in (2x).
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL81345.091.23 |
| Other | Volgt nog |