- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02264951
Fat-induced Release of GLP-1 in Humans
October 9, 2014 updated by: Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen
Short Fatty Acids-induced Release of GLP-1 in Humans
This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of 20 ml olive oil on a molar basis in human volunteers.
Study Overview
Status
Completed
Conditions
Detailed Description
A structured triglyceride (1,3-di-octanoyl-2-oleoyl-glycerol, called C8-diet oil), which upon digestion results in generation of two medium-chain fatty acids and 2-oleoyl-glycerol (2-OG), may lead to activation of GPR119 only, since medium fatty acids are poor agonists for fatty acid receptors.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Caucasian healthy male subjects
- Body mass index (BMI) 19 to 25 kg/m2
- Informed consent
Exclusion Criteria:
- Anaemia
- Diabetes mellitus
- Gastrointestinal diseases or operations interacting with intestinal absorption
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A meal containing carrot and tributyrin
A meal containing 200 g grated carrot and 0.0216 mol tributyrin; blood test taken from 0 - 2 hours postprandial
|
a triglyceride containing three C4-acids
mainly water and glucose
|
Active Comparator: A meal containing carrot and C8-diet oil
A meal containing 200 g grated carrot and 0.0216 mol of C8-diet oil; blood test taken from 0 - 2 hours postprandial
|
mainly water and glucose
a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position
|
Active Comparator: A meal containing carrot and olive oil
A meal containing 200 g grated carrot and 0.0216 mol of olive oil; blood test taken from 0 - 2 hours postprandial
|
mainly water and glucose
a triglyceride containing mostly three oleic acids
|
Placebo Comparator: A meal containing carrot
A meal containing 200 g grated carrot; blood test taken from 0 - 2 hours postprandial
|
mainly water and glucose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma GLP-1
Time Frame: 2 hours postprandial
|
2 hours postprandial
|
plasma GIP
Time Frame: 2 hours postprandial
|
2 hours postprandial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma insulin
Time Frame: 2 hours postprandial
|
2 hours postprandial
|
plasma PYY
Time Frame: 2 hours postprandial
|
2 hours postprandial
|
plasma glucose
Time Frame: 2 hours postprandial
|
2 hours postprandial
|
plasma neurotensin
Time Frame: 2 hour postprandial
|
2 hour postprandial
|
plasma CCK
Time Frame: 2 hour postprandial
|
2 hour postprandial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Jens J Holst, Professor, Biomedical Sciences, University of Copenhagen
- Principal Investigator: Mette J Mandøe, Student, Glostrup Hospital; Biomedical Sciences, University of Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
October 9, 2014
First Submitted That Met QC Criteria
October 9, 2014
First Posted (Estimate)
October 15, 2014
Study Record Updates
Last Update Posted (Estimate)
October 15, 2014
Last Update Submitted That Met QC Criteria
October 9, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- SFAS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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