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…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are gastric emptying and gallbladder volume.
Secondary outcome
Secondary study parameters are plasma CCK, plant sterol concentrations.
Background summary
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.
Study objective
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.
Study design
We will implement a randomized controlled cross-over design.
Intervention
Consumption of plant sterol containing drinks and test meals.
Study burden and risks
All products that will be used for the study, are harmless. Both, the plant
sterol containing drink as well as the standardized meal that will be used in
this study, are commercially available. Paracetamol and 13C octanoic acid are
pharmaceutically tested and are safe.
Echoscopy and breath sample donnation are both without any risk for the
volunteer. Insertion of the cannula may cause a bruise or swelling afterwards.
Further complications that may be involved with blood sampling are a perceived
sense of dizziness or fainting, due to blood exposure.
P.O. Box 616
6200 MD
NL
P.O. Box 616
6200 MD
NL
Listed location countries
Age
Inclusion criteria
• Signed informed consent form
• Sex: male
• Age: 18-55 years
• Body Mass Index (BMI): 20-30 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.
• Blood donations less than three months previous to study enrolment.
• Known hypersensitivity or allergy towards paracetamol.
• Hyperlipidaedimia (TG > 3 mmol/L and/or tot. chol. > 8 mmol/L)
• Corn products prior to treatment (<= 48 hour)
• Presence of gallbladder stones
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00940849 |
| CCMO | NL27585.068.09 |