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Completed

NCT Number: NCT00940849

Gastric Emptying and Gallbladder Motility Study

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.

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Key information

Conditions

Gastric Emptying

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6200, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant sterol containing drink

Dietary Supplement

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

Standard macaroni meal

Dietary Supplement

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

Primary outcomes

  1. GB volume measurement by ultrasonography

    Time frame: September 2009

Secondary outcomes

  1. GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis

    Time frame: December 2009

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Unilever R&D

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 16, 2009
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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