Gastric Emptying and Gallbladder Motility Study
Status
Conditions
Treatments
Details and patient eligibility
About
Background of the study:
Plant sterols can play an important role in lowering plasma cholesterol. The extent to which plant sterols can reduce plasma cholesterol levels depends on the intake scenario. We suggest that the difference in these effects depends on gastric emptying and bile secretion.
Objective of the study:
The aim of this study is to gain insight in the mechanisms that may be involved in the effects of plant sterol drinks on gastric emptying and gallbladder motility. In order to test this, we compare the different effects of the consumption of a plant sterol containing drink prior to, during and after a standardized meal.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Signed informed consent form
- Sex: male
- Age: 18-55 years
- Body Mass Index (BMI): 20-25 kg/m2
Exclusion criteria
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery which might limit participation in or completion of the study protocol.
- Use of any medication on regular basis.
- Use of paracetamol prior to treatment (≤ 48 hour).
- Use of plant sterol/stanol enriched products or supplements 3 months prior to the study.
- Blood donations less than three months previous to study enrolment.
- Known hypersensitivity or allergy towards paracetamol.
- Hyperlipidaemia (TG > 3 mmol/L and/or tot. chol. > 8 mmol/L)
- Corn products prior to treatment (≤ 48 hour)
- Presence of gallbladder stones.
- Known allergy for cow milk and/or lactose intolerance
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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