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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Maastricht University Medical Center

Maastricht, Limburg, Netherlands, 6200