Gastric Emptying
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlant sterol containing drink
The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
DIETARY_SUPPLEMENTStandard macaroni meal
The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
Sponsors
Unilever R&D
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GB volume measurement by ultrasonography | September 2009 |
Secondary
| Measure | Time frame |
|---|---|
| GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis | December 2009 |
Countries
Netherlands
Outcome results
None listed