Status:
COMPLETED
Gastric Emptying and Gallbladder Motility Study
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Unilever R&D
Conditions:
Gastric Emptying
Eligibility:
MALE
18-55 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Signed informed consent form
- Sex: male
- Age: 18-55 years
- Body Mass Index (BMI): 20-25 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00940849
Start Date
October 1 2009
End Date
October 1 2010
Last Update
November 13 2014
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6200