Gastric Emptying and Gallbladder Motility Study

Not Applicable

Completed

• Conditions: Gastric Emptying
• Interventions: Dietary Supplement: Plant sterol containing drink; Dietary Supplement: Standard macaroni meal

• Registration Number: NCT00940849
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Study Start: 2009-10
• Primary Completion: 2009-12
• Study Completion: 2010-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary Supplement: Plant sterol containing drink	Standard macaroni meal	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	Plant sterol containing drink	The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal

Primary Outcome Measures

Name	Time	Method
GB volume measurement by ultrasonography	September 2009

Secondary Outcome Measures

Name	Time	Method
GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis	December 2009

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands