Healthy ParticipantsGPR146NCT07142317
GPR146 and Cholesterol Metabolism
A study testing Cholesterol-poor, plant sterol-poor shake, Cholesterol-rich, plant sterol-poor shake and Cholesterol-rich, plant sterol-rich shake in people with Healthy Participants, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Blood cholesterol balance is regulated by an interplay between the small intestine and the liver. Recently, a new protein (cholesin) was discovered, which is secreted by intestinal cells after dietary cholesterol intake. Cholesin travels to the liver and binds to the GPR146 receptor. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Cholesterol-poor, plant sterol-poor shake, Cholesterol-rich, plant sterol-poor shake and Cholesterol-rich, plant sterol-rich shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, aged between 18-70 years
- BMI between 18.5-25.0 kg/m2
- Fasting serum total cholesterol (TC) <8.0 mmol/L and fasting serum triacylglycerol (TAG) <3 mmol/L
- Fasting plasma glucose (FBG) <7 mmol/L
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
- Stable body weight (weight gain or loss of <3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study, and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
Who cannot join
- Allergy or intolerance to any of the components of the study meal
- Familial hypercholesterolemia
- History of gastrointestinal surgery, including bariatric procedures such as sleeve gastrectomy, gastric bypass, gastric band, gastric balloon, or other major gastrointestinal surgeries that may affect digestion or absorption
- Current smokers
- Diabetic patients
- Pregnant and breastfeeding women
Show all 13Show fewer
- Abuse of drugs
- More than 10 alcoholic consumptions per week for women and 14 for men
- Not willing to stop the use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigator for at least 1 week before the start of the study
- Use of medications to treat or affect blood pressure, lipid, or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1 month
- Severe medical conditions that might interfere with the study, such as: epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, autoinflammatory diseases, and rheumatoid arthritis
- Active cardiovascular disease, such as congestive heart failure, or a cardiovascular event, such as an acute myocardial infarction or a cerebrovascular accident
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Maastricht University
Maastricht, Limburg, 6229 ER
Nele Steenackers, PhD, +31-433881539, nele.steenackers@maastrichtuniversity.nl
Jogchum Plat, PhD
About this study
Official title: The Impact of Plant Sterols on the Dietary Cholesterol-Induced Expression of GPR146: A Randomized Double-Blind Cross-Over Study
Blood cholesterol balance is regulated by an interplay between the small intestine and the liver. Recently, a new protein (cholesin) was discovered, which is secreted by intestinal cells after dietary cholesterol intake. Cholesin travels to the liver and binds to the GPR146 receptor. This inhibits cholesterol production in the liver. Because plant sterols lower blood cholesterol levels by reducing cholesterol absorption in the intestine, the investigators would like to understand the effects of plant sterols on GPR146. The investigator hypothesis is that the production of the GPR146 gene differs after adding plant sterols to a high-cholesterol diet compared to eating a high-cholesterol and low-cholesterol diet. The main objective of this study is to investigate whether the expression of the GPR146 gene in the blood of adults differs between three meals with different levels of cholesterol intake. The secondary objective of the study is to examine changes in the expression of cholesin, the LDL receptor (LDLR), and 3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) genes in the blood after these meals. Furthermore, changes in the expression of these genes, all of which play an important role in cholesterol metabolism, will be examined in intestinal cells.
- Conditions
- Healthy Participants
- Being tested
- Cholesterol-poor, plant sterol-poor shake, Cholesterol-rich, plant sterol-poor shake, Cholesterol-rich, plant sterol-rich shake
- Keywords
- GPR146, Cholesin, Cholesterol metabolism, Gene expression, Postprandial study, Intestinal cholesterol absorption, Hepatic cholesterol synthesis, Plant sterols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholesterol-poor, plant sterol-poor shakeDietary supplement
The first arm is the cholesterol-poor arm, where participants will be given a mixed meal in the form of a cholesterol-poor, plant-sterol-poor shake which provides the lowest cholesterol absorption rate.
Cholesterol-rich, plant sterol-poor shakeDietary supplement
The second arm is the high-cholesterol arm, where participants will be given a mixed meal in the form of a cholesterol-rich, plant-sterol-poor shake, which provides the highest cholesterol absorption rate.
Cholesterol-rich, plant sterol-rich shakeDietary supplement
The third arm is the moderate-cholesterol arm, where participants will be given a mixed meal in the form of a cholesterol-rich, plant-sterol-rich shake, which provides the moderate cholesterol absorption rate.
| Study group | Role | What they receive |
|---|---|---|
| Cholesterol-poor, plant sterol-poor shake | Active comparator | Participants will be given a mixed meal in the form of a cholesterol-poor, plant-sterol-poor shake. Receives: Dietary Supplement: Cholesterol-poor, plant sterol-poor shake |
| Cholesterol-rich, plant sterol-poor shake | Active comparator | Participants will be given a mixed meal in the form of a cholesterol-rich, plant-sterol-poor shake. Receives: Dietary Supplement: Cholesterol-rich, plant sterol-poor shake |
| Cholesterol-rich plant sterol-rich shake | Experimental | Participants will be given a mixed meal in the form of a cholesterol-rich, plant-sterol-rich shake. Receives: Dietary Supplement: Cholesterol-rich, plant sterol-rich shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postprandial changes in GPR146 gene expression in peripheral blood mononuclear cells (PBMCs) after three dietary conditions.
The gene expression levels will be determined by messenger RNA (mRNA) quantification using the real-time reverse transcription polymerase chain reaction (RT-qPCR) method in PBMCs and reported as fold change (increase or decrease) relative to baseline.
Measured: At baseline (fasting; before the meal) and at 360 minutes (6-hours) postprandial
Secondary outcomes (2)
The postprandial changes in C7orf50, HMGCR, and LDLR gene expressions in peripheral blood mononuclear cells (PBMCs) after three dietary conditions.
The gene expression levels will be determined by messenger RNA (mRNA) quantification using the real-time reverse transcription polymerase chain reaction (RT-qPCR) method in PBMCs and reported as fold change (increase or decrease) relative to baseline
Measured: At baseline (fasting; before the meal) and at 360 minutes (6-hours) postprandial
The postprandial changes in GPR146 and LDLR protein expressions in peripheral blood mononuclear cells after three dietary conditions.
The protein expression levels will be measured by fluorescence-activated cell sorting (FACS) analysis and reported as percentage of marker-positive cells and/or fold change in mean fluorescence intensity from baseline.
Measured: At baseline (fasting; before the meal) and at 360 minutes (6-hours) postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142317
- Sponsor's protocol ID
- METC 25-027
- Acronym
- GPR146
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to data protection and participants' confidentiality, this will be decided by the principal investigator based on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Plant Sterols on the Dietary Cholesterol-Induced Expression of GPR146: A Randomized Double-Blind Cross-Over Study
- ClinicalTrials.gov ID
- NCT07142317
- Acronym / sponsor ID
- GPR146 / METC 25-027
- Conditions
- Healthy Participants
- Keywords
- GPR146, Cholesin, Cholesterol metabolism, Gene expression, Postprandial study, Intestinal cholesterol absorption, Hepatic cholesterol synthesis, Plant sterols
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Aug 2025 (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.
Blood cholesterol balance is regulated by an interplay between the small intestine and the liver. Recently, a new protein (cholesin) was discovered, which is secreted by intestinal cells after dietary cholesterol intake. Cholesin travels to the liver and binds to the GPR146 receptor. This inhibits cholesterol production in the liver. Because plant sterols lower blood cholesterol levels by reducing cholesterol absorption in the intestine, the investigators would like to understand the effects of plant sterols on GPR146. The investigator hypothesis is that the production of the GPR146 gene differs after adding plant sterols to a high-cholesterol diet compared to eating a high-cholesterol and low-cholesterol diet. The main objective of this study is to investigate whether the expression of the GPR146 gene in the blood of adults differs between three meals with different levels of cholesterol intake. The secondary objective of the study is to examine changes in the expression of cholesin, the LDL receptor (LDLR), and 3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) genes in the blood after these meals. Furthermore, changes in the expression of these genes, all of which play an important role in cholesterol metabolism, will be examined in intestinal cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cholesterol-poor, plant sterol-poor shake | Active comparator | Dietary Supplement: Cholesterol-poor, plant sterol-poor shakeParticipants will be given a mixed meal in the form of a cholesterol-poor, plant-sterol-poor shake. |
| Cholesterol-rich, plant sterol-poor shake | Active comparator | Dietary Supplement: Cholesterol-rich, plant sterol-poor shakeParticipants will be given a mixed meal in the form of a cholesterol-rich, plant-sterol-poor shake. |
| Cholesterol-rich plant sterol-rich shake | Experimental | Dietary Supplement: Cholesterol-rich, plant sterol-rich shakeParticipants will be given a mixed meal in the form of a cholesterol-rich, plant-sterol-rich shake. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women, aged between 18-70 years
- BMI between 18.5-25.0 kg/m2
- Fasting serum total cholesterol (TC) <8.0 mmol/L and fasting serum triacylglycerol (TAG) <3 mmol/L
- Fasting plasma glucose (FBG) <7 mmol/L
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
Key exclusion criteria (13 listed)
- Allergy or intolerance to any of the components of the study meal
- Familial hypercholesterolemia
- History of gastrointestinal surgery, including bariatric procedures such as sleeve gastrectomy, gastric bypass, gastric band, gastric balloon, or other major gastrointestinal surgeries that may affect digestion or absorption
- Current smokers
- Diabetic patients
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 |
|---|---|---|
| Cholesterol-poor, plant sterol-poor shakeThe first arm is the cholesterol-poor arm, where participants will be given a mixed meal in the form of a cholesterol-poor, plant-sterol-poor shake which provides the lowest cholesterol absorption rate. | Dietary supplement | Cholesterol-poor, plant sterol-poor shake |
| Cholesterol-rich, plant sterol-poor shakeThe second arm is the high-cholesterol arm, where participants will be given a mixed meal in the form of a cholesterol-rich, plant-sterol-poor shake, which provides the highest cholesterol absorption rate. | Dietary supplement | Cholesterol-rich, plant sterol-poor shake |
| Cholesterol-rich, plant sterol-rich shakeThe third arm is the moderate-cholesterol arm, where participants will be given a mixed meal in the form of a cholesterol-rich, plant-sterol-rich shake, which provides the moderate cholesterol absorption rate. | Dietary supplement | Cholesterol-rich plant sterol-rich shake |
Primary outcome
The postprandial changes in GPR146 gene expression in peripheral blood mononuclear cells (PBMCs) after three dietary conditions.
Time frame: At baseline (fasting; before the meal) and at 360 minutes (6-hours) postprandial
The gene expression levels will be determined by messenger RNA (mRNA) quantification using the real-time reverse transcription polymerase chain reaction (RT-qPCR) method in PBMCs and reported as fold change (increase or decrease) relative to baseline.
2 secondary outcomes
The postprandial changes in C7orf50, HMGCR, and LDLR gene expressions in peripheral blood mononuclear cells (PBMCs) after three dietary conditions.
Time frame: At baseline (fasting; before the meal) and at 360 minutes (6-hours) postprandial
The postprandial changes in GPR146 and LDLR protein expressions in peripheral blood mononuclear cells after three dietary conditions.
Time frame: At baseline (fasting; before the meal) and at 360 minutes (6-hours) postprandial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided. Due to data protection and participants' confidentiality, this will be decided by the principal investigator based on a reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholesterol-poor, plant sterol-poor shake, Cholesterol-rich, plant sterol-poor shake and Cholesterol-rich, plant sterol-rich shake in people with Healthy Participants, run by Maastricht University Medical Center 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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 1 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jogchum Plat, PhD (+31-43-3881309, j.plat@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postprandial changes in GPR146 gene expression in peripheral blood mononuclear cells (PBMCs) after three dietary conditions. (time frame: At baseline (fasting; before the meal) and at 360 minutes (6-hours) postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.