Gastric EmptyingNCT00940849
Gastric Emptying and Gallbladder Motility Study
A study testing Plant sterol containing drink and Standard macaroni meal in people with Gastric Emptying, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- Plant sterol containing drink and Standard macaroni meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form
- Sex: male
- Age: 18-55 years
- Body Mass Index (BMI): 20-25 kg/m2
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6200
About this study
Official title: Gastric Emptying of Plant Sterol-containing Mini Drinks in Different Meal Intake Scenarios and Their Effect on Gallbladder Emptying
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.
- Conditions
- Gastric Emptying
- Being tested
- Plant sterol containing drink, Standard macaroni meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterol containing drinkDietary supplement
The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
Standard macaroni mealDietary supplement
The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Plant sterol containing drink | Experimental | The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal Receives: Dietary Supplement: Plant sterol containing drink; Dietary Supplement: Standard macaroni meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
GB volume measurement by ultrasonography
Measured: September 2009
Secondary outcomes (1)
GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis
Measured: December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Ad Masclee, MD PhD, Principal investigator, Maastrich University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940849
- Sponsor's protocol ID
- MEC 09-2-042
- Status last verified
- Nov 2014
- First submitted
- 15 Jul 2009
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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/s00394-012-0440-3. Epub 2012 Aug 23.
PubMed 22915051
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying of Plant Sterol-containing Mini Drinks in Different Meal Intake Scenarios and Their Effect on Gallbladder Emptying
- ClinicalTrials.gov ID
- NCT00940849
- Acronym / sponsor ID
- MEC 09-2-042
- Conditions
- Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Plant sterol containing drink | Experimental | Dietary Supplement: Plant sterol containing drink, Dietary Supplement: Standard macaroni mealThe test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Sex: male
- Age: 18-55 years
- Body Mass Index (BMI): 20-25 kg/m2
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant sterol containing drinkThe test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal | Dietary supplement | Dietary Supplement: Plant sterol containing drink |
| Standard macaroni mealThe test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal | Dietary supplement | Dietary Supplement: Plant sterol containing drink |
Primary outcome
GB volume measurement by ultrasonography
Time frame: September 2009
1 secondary outcome
GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis
Time frame: December 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Results publication: PubMed 22915051Keszthelyi 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/s00394-012-0440-3. Epub 2012 Aug 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ad Masclee, MD PhD principal investigator
Maastrich University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant sterol containing drink and Standard macaroni meal in people with Gastric Emptying, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GB volume measurement by ultrasonography (time frame: September 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.