Small IntestineTAPIRNCT06064266
Healthy Fat, Happy Microbiome (TAPIR), Proof-of-Concept Study
A study testing high-fat shake in people with Small Intestine, run by Wageningen University at 1 site in Netherlands.
Trial 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 intestinal microbiome, fecal-oriented studies might have missed their important, local effect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Small Intestine
- What is being tested?
- high-fat shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Oct 2023to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female
- BMI 18.5-30 kg/m2
- Suitable veins for insertion of cannula
Who cannot join
- 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)
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 intestinal microbiome, fecal-oriented studies might have missed their important, local effect. Indications for an interaction between dietary lipids and the small intestinal microbiome are mainly based on animal studies, but human data are largely missing. This study therefore aims at exploring this principal in vivo in healthy individuals.
Primary objective: To assess the effect of dietary lipids on the small intestinal microbiome in humans (proof-of-concept), the primary objective of our study is to measure production of microbiota-derived lipid metabolites in the human small intestine after consumption of a plant-based high-fat shake in healthy pre-conditioned subjects.
Read more
Secondary objectives: To explore future perspectives for dietary lipid - small intestinal microbiome interactive research, the secondary objectives of our study are
- To compare the levels of microbiota-derived lipid metabolites in aspirate samples obtained through 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);
- To investigate the acute effect of a high-fat shake on the composition and transcriptome 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;
- To study and compare the effect of a 8-day plant-based mild ketogenic preconditioning diet on the composition of the small intestine microbiota (aspiration capsule) and the fecal microbiota.
Study design: Proof-of-concept intervention study
Study population: 16 healthy adults, BMI between 18.5-30 kg/m2.
Intervention: 8-days preconditioning mild ketogenic controlled diet followed by a high fat shake challenge with a naso-intestinal catheter.
Main study parameters/endpoints: The primary study parameters are the microbial-derived metabolites from linoleic acid and plant sterols after consumption of the high fat shake.
Secondary study parameters include microbiota composition and transcriptome activity. Other parameters include inflammatory markers and ex-vivo analyses.
- Conditions
- Small Intestine
- Being tested
- plant-based mild ketogenic controlled diet, high-fat shake
- Keywords
- Dietary fat, Microbial metabolites, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant-based mild ketogenic controlled dietOther
Plant-based mild ketogenic diet (10-20EN% carbohydrates, 10-20EN% protein, and 60-70EN% fat), consisting of a daily breakfast, lunch, dinner, and snacks.
high-fat shakeOther
The high-fat shake consists of unsweetened almond milk, sunflower oil, and plant sterols, resulting in a shake containing 885 kcal (1.5g protein, 97.3g fat, and 0.8g sugar).
| Study group | Role | What they receive |
|---|---|---|
| 8-days plant-based preconditioning mild ketogenic controlled diet followed by a high-fat shake. | Experimental | Not described Receives: Other: plant-based mild ketogenic controlled diet; Other: high-fat shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid metabolites from linoleic acid and plant sterols in the small intestine aspirates
Concentrations of microbiota-derived lipid metabolites in the small intestine aspirates, obtained by a naso-intestinal catheter, measured by lipidomics.
Measured: 0-6 hours
Secondary outcomes (9)
lipid metabolites in small intestine aspirate samples obtained with an aspiration capsule.
Concentrations of microbiota-derived lipid metabolites in the small intestine aspirates, obtained by an aspiration capsule, measured by lipidomics.
Measured: 0-6 hours
small intestine microbiota composition
The relative composition (%) of the small intestine microbiota in aspirate samples obtained by an intestinal catheter.
Measured: 0-6 hours
small intestine microbiome capacity
The functional capacity (transcriptomic activity) of the small intestine microbiota in aspirate samples obtained by an intestinal catheter.
Measured: 0-6 hours
Faecal microbiota
The relative composition (%) of the faecal microbiota
Measured: Baseline, after 8 days.
Blood lipid metabolites
Lipid metabolites (HYA, CLA, all untargeted lipid metabolites) will be measured in blood samples with lipidomics.
Measured: 0-6 hours
Blood triglycerides
Concentrations of triglycerides
Measured: 0-6 hours
Blood free fatty acids
Concentrations of free fatty acids
Measured: 0-6 hours
small intestine microbiota
The relative composition (%) of the small intestine microbiota in aspirates obtained by an aspiration capsule.
Measured: Baseline, after 5 days.
small intestine microbiome
The functional capacity (transcriptomic activity) of the small intestine microbiota in aspirates obtained by an aspiration capsule.
Measured: Baseline, after 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start20 Oct 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small IntestineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 8-days preconditioning mild ketogenic controlled diet followed by a high fat shake challenge with a naso-intestinal catheter.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research
- Responsible party
- Principal investigator, Mara van Trijp, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064266
- Sponsor's protocol ID
- NL81345.081.23
- Acronym
- TAPIR
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
JanssenDuijghuijsen L, Fransen K, Deng R, Perenboom C, de Wit N, Hooiveld G, van Trijp M. How to Study the Effects of Dietary Lipids on the Small Intestinal Microbiome? Methodological Design and Evaluation of the Human HealThy fAt, haPpy mIcRobiome (TAPIR) Proof-of-Concept Study. Curr Dev Nutr. 2025 Feb 5;9(3):104564. doi: 10.1016/j.cdnut.2025.104564. eCollection 2025 Mar.
PubMed 40092654
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Fat, Happy Microbiome (TAPIR), Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT06064266
- Acronym / sponsor ID
- TAPIR / NL81345.081.23
- Conditions
- Small Intestine
- Keywords
- Dietary fat, Microbial metabolites, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Wageningen University and Research
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 intestinal microbiome, fecal-oriented studies might have missed their important, local effect. Indications for an interaction between dietary lipids and the small intestinal microbiome are mainly based on animal studies, but human data are largely missing. This study therefore aims at exploring this principal in vivo in healthy individuals.
Primary objective: To assess the effect of dietary lipids on the small intestinal microbiome in humans (proof-of-concept), the primary objective of our study is to measure production of microbiota-derived lipid metabolites in the human small intestine after consumption of a plant-based high-fat shake in healthy pre-conditioned subjects.
Secondary objectives: To explore future perspectives for dietary lipid - small intestinal microbiome interactive research, the secondary objectives of our study are
- To compare the levels of microbiota-derived lipid metabolites in aspirate samples obtained through 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);
- To investigate the acute effect of a high-fat shake on the composition and transcriptome 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;
- To study and compare the effect of a 8-day plant-based mild ketogenic preconditioning diet on the composition of the small intestine microbiota (aspiration capsule) and the fecal microbiota.
Study design: Proof-of-concept intervention study
Study population: 16 healthy adults, BMI between 18.5-30 kg/m2.
Intervention: 8-days preconditioning mild ketogenic controlled diet followed by a high fat shake challenge with a naso-intestinal catheter.
Main study parameters/endpoints: The primary study parameters are the microbial-derived metabolites from linoleic acid and plant sterols after consumption of the high fat shake.
Secondary study parameters include microbiota composition and transcriptome activity. Other parameters include inflammatory markers and ex-vivo analyses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 8-days preconditioning mild ketogenic controlled diet followed by a high fat shake challenge with a naso-intestinal catheter.
| Arm | Type | Receives |
|---|---|---|
| 8-days plant-based preconditioning mild ketogenic controlled diet followed by a high-fat shake. | Experimental | Other: plant-based mild ketogenic controlled diet, Other: high-fat shake |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male or female
- BMI 18.5-30 kg/m2
- Suitable veins for insertion of cannula
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plant-based mild ketogenic controlled dietPlant-based mild ketogenic diet (10-20EN% carbohydrates, 10-20EN% protein, and 60-70EN% fat), consisting of a daily breakfast, lunch, dinner, and snacks. | Other | 8-days plant-based preconditioning mild ketogenic controlled diet followed by a high-fat shake. |
| high-fat shakeThe high-fat shake consists of unsweetened almond milk, sunflower oil, and plant sterols, resulting in a shake containing 885 kcal (1.5g protein, 97.3g fat, and 0.8g sugar). | Other | 8-days plant-based preconditioning mild ketogenic controlled diet followed by a high-fat shake. |
Primary outcome
lipid metabolites from linoleic acid and plant sterols in the small intestine aspirates
Time frame: 0-6 hours
Concentrations of microbiota-derived lipid metabolites in the small intestine aspirates, obtained by a naso-intestinal catheter, measured by lipidomics.
9 secondary outcomes
lipid metabolites in small intestine aspirate samples obtained with an aspiration capsule.
Time frame: 0-6 hours
small intestine microbiota composition
Time frame: 0-6 hours
small intestine microbiome capacity
Time frame: 0-6 hours
Faecal microbiota
Time frame: Baseline, after 8 days.
Blood lipid metabolites
Time frame: 0-6 hours
Blood triglycerides
Time frame: 0-6 hours
Blood free fatty acids
Time frame: 0-6 hours
small intestine microbiota
Time frame: Baseline, after 5 days.
small intestine microbiome
Time frame: Baseline, after 5 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 40092654JanssenDuijghuijsen L, Fransen K, Deng R, Perenboom C, de Wit N, Hooiveld G, van Trijp M. How to Study the Effects of Dietary Lipids on the Small Intestinal Microbiome? Methodological Design and Evaluation of the Human HealThy fAt, haPpy mIcRobiome (TAPIR) Proof-of-Concept Study. Curr Dev Nutr. 2025 Feb 5;9(3):104564. doi: 10.1016/j.cdnut.2025.104564. eCollection 2025 Mar.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-fat shake in people with Small Intestine, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipid metabolites from linoleic acid and plant sterols in the small intestine aspirates (time frame: 0-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.