Cholesterol homeostasis, intestinal cholesterol absorption Cholesterol balance in the body
Conditions
Interventions
On each intervention day, the study participants will receive one of three mixed meals in the form of a shake: a cholesterol-poor plant sterol-poor, a cholesterol-rich plant sterol-poor, or a choleste
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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 blood glucose (FBG) <7 mmol/LSystolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHgStable body weight (weight gain or loss <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 studyNo difficult venipuncture as evidenced during the screening visit
Exclusion criteria
Exclusion criteria: Allergy or intolerance to any of the components of the study mealFamilial hypercholesterolemiaHistory 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 absorptionCurrent smokersDiabetic patientsAbuse of drugsMore than 10 alcoholic consumptions per week for women and 14 for menNot willing to stop the use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators for at least 1 week before the start of the studyUse of medications to treat or affect blood pressure, lipid, or glucose metabolismUse of an investigational product within another biomedical intervention trial within the previous 3 weeksSevere 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 arthritisActive cardiovascular disease such as congestive heart failure, or a cardiovascular event such as an acute myocardial infarction or a cerebrovascular accident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the difference between the change in GPR146 gene expression after three dietary conditions – a cholesterol-poor PS-poor shake, a cholesterol-rich PS-poor shake, and a cholesterol-rich PS-rich shake – in PBMCs. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study endpoints will be the difference between the change in C7orf50, HMGCR, and LDLR genes expression levels and GPR146 and LDLR protein expression levels in PBMCs between the three shakes, as well as the changes in small intestinal mucosal cells expression profiles of the 4 aforementioned genes between the shakes. | — |
Countries
Netherlands
Contacts
Public ContactJP Plat
Universiteit Maastricht
Outcome results
None listed