Gastric Emptying and Gallbladder Motility Study

Study Overview
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Brief Summary
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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.

Official Title
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Gastric Emptying of Plant Sterol-containing Mini Drinks in Different Meal Intake Scenarios and Their Effect on Gallbladder Emptying

Conditions
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Gastric Emptying

Intervention / Treatment
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* Dietary Supplement: Plant sterol containing drink
* Dietary Supplement: Standard macaroni meal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Supplement: Plant sterol containing drink<br>The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal | Dietary Supplement: Plant sterol containing drink<br>* The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal<br>Dietary Supplement: Standard macaroni meal<br>* The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GB volume measurement by ultrasonography |  | September 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis |  | December 2009 |