Status:
NOT_YET_RECRUITING
GPR146 and Cholesterol Metabolism
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Healthy Participants
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT07142317
Start Date
October 1 2025
End Date
December 1 2026
Last Update
October 1 2025
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 6229 ER