Gastric Emptying and Gallbladder Motility Study

Gastric Emptying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940849
• Other study ID #: MEC 09-2-042
• Status: Completed
• Phase: N/A
• First received: July 15, 2009
• Last updated: November 11, 2014
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gastric Emptying

Intervention

Dietary Supplement:
• 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
• Standard macaroni meal
The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Unilever R&D

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Keszthelyi D, Knol D, Troost FJ, van Avesaat M, Foltz M, Masclee AA. Time of ingestion relative to meal intake determines gastrointestinal responses to a plant sterol-containing yoghurt drink. Eur J Nutr. 2013 Jun;52(4):1417-20. doi: 10.1007/s00394-012-04 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GB volume measurement by ultrasonography		September 2009	No
Secondary	GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis		December 2009	No