Type 2 DiabetesNCT02264951
Fat-induced Release of GLP-1 in Humans
A study testing Tributyrin, C8-diet oil and Olive oil in people with Type 2 Diabetes, run by Glostrup University Hospital, Copenhagen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tributyrin, C8-diet oil and Olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Feb 2014
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian healthy male subjects
- Body mass index (BMI) 19 to 25 kg/m2
- Informed consent
Who cannot join
- Anaemia
- Diabetes mellitus
- Gastrointestinal diseases or operations interacting with intestinal absorption
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Tributyrin, C8-diet oil, Olive oil, Carrot
- Keywords
- Short fatty acids, 2-oleoyl glycerol, GLP-1 secretion, C8-diet oil, GIP secretion
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TributyrinDietary supplement
a triglyceride containing three C4-acids
C8-diet oilDietary supplement
a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position
Olive oilDietary supplement
a triglyceride containing mostly three oleic acids
CarrotDietary supplement
mainly water and glucose
| Study group | Role | What they receive |
|---|---|---|
| A meal containing carrot and tributyrin | Active comparator | A meal containing 200 g grated carrot and 0.0216 mol tributyrin; blood test taken from 0 - 2 hours postprandial Receives: Dietary Supplement: Tributyrin; Dietary Supplement: Carrot |
| A meal containing carrot and C8-diet oil | Active comparator | A meal containing 200 g grated carrot and 0.0216 mol of C8-diet oil; blood test taken from 0 - 2 hours postprandial Receives: Dietary Supplement: C8-diet oil; Dietary Supplement: Carrot |
| A meal containing carrot and olive oil | Active comparator | A meal containing 200 g grated carrot and 0.0216 mol of olive oil; blood test taken from 0 - 2 hours postprandial Receives: Dietary Supplement: Olive oil; Dietary Supplement: Carrot |
| A meal containing carrot | Placebo comparator | A meal containing 200 g grated carrot; blood test taken from 0 - 2 hours postprandial Receives: Dietary Supplement: Carrot |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma GLP-1
Measured: 2 hours postprandial
plasma GIP
Measured: 2 hours postprandial
Secondary outcomes (5)
plasma insulin
Measured: 2 hours postprandial
plasma PYY
Measured: 2 hours postprandial
plasma glucose
Measured: 2 hours postprandial
plasma neurotensin
Measured: 2 hour postprandial
plasma CCK
Measured: 2 hour postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionFeb 2014
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 Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen
- Investigators
- Jens J Holst, Professor, Study chair, Biomedical Sciences, University of CopenhagenMette J Mandøe, Student, Principal investigator, Glostrup Hospital; Biomedical Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264951
- Sponsor's protocol ID
- SFAS
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mandoe MJ, Hansen KB, Hartmann B, Rehfeld JF, Holst JJ, Hansen HS. The 2-monoacylglycerol moiety of dietary fat appears to be responsible for the fat-induced release of GLP-1 in humans. Am J Clin Nutr. 2015 Sep;102(3):548-55. doi: 10.3945/ajcn.115.106799. Epub 2015 Jul 15.
PubMed 26178726
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Fatty Acids-induced Release of GLP-1 in Humans
- ClinicalTrials.gov ID
- NCT02264951
- Acronym / sponsor ID
- SFAS
- Conditions
- Type 2 Diabetes
- Keywords
- Short fatty acids, 2-oleoyl glycerol, GLP-1 secretion, C8-diet oil, GIP secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Oct 2014 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A meal containing carrot and tributyrin | Active comparator | Dietary Supplement: Tributyrin, Dietary Supplement: CarrotA meal containing 200 g grated carrot and 0.0216 mol tributyrin; blood test taken from 0 - 2 hours postprandial |
| A meal containing carrot and C8-diet oil | Active comparator | Dietary Supplement: C8-diet oil, Dietary Supplement: CarrotA meal containing 200 g grated carrot and 0.0216 mol of C8-diet oil; blood test taken from 0 - 2 hours postprandial |
| A meal containing carrot and olive oil | Active comparator | Dietary Supplement: Olive oil, Dietary Supplement: CarrotA meal containing 200 g grated carrot and 0.0216 mol of olive oil; blood test taken from 0 - 2 hours postprandial |
| A meal containing carrot | Placebo comparator | Dietary Supplement: CarrotA meal containing 200 g grated carrot; blood test taken from 0 - 2 hours postprandial |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Caucasian healthy male subjects
- Body mass index (BMI) 19 to 25 kg/m2
- Informed consent
Key exclusion criteria (3 listed)
- Anaemia
- Diabetes mellitus
- Gastrointestinal diseases or operations interacting with intestinal absorption
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 |
|---|---|---|
| Tributyrina triglyceride containing three C4-acids | Dietary supplement | A meal containing carrot and tributyrin |
| C8-diet oila triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position | Dietary supplement | A meal containing carrot and C8-diet oil |
| Olive oila triglyceride containing mostly three oleic acids | Dietary supplement | A meal containing carrot and olive oil |
| Carrotmainly water and glucose | Dietary supplement | A meal containing carrot, A meal containing carrot and C8-diet oil, A meal containing carrot and olive oil, A meal containing carrot and tributyrin |
Primary outcome
plasma GLP-1
Time frame: 2 hours postprandial
plasma GIP
Time frame: 2 hours postprandial
5 secondary outcomes
plasma insulin
Time frame: 2 hours postprandial
plasma PYY
Time frame: 2 hours postprandial
plasma glucose
Time frame: 2 hours postprandial
plasma neurotensin
Time frame: 2 hour postprandial
plasma CCK
Time frame: 2 hour postprandial
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 15 Oct 2014.
- Derived from this study: PubMed 26178726Mandoe MJ, Hansen KB, Hartmann B, Rehfeld JF, Holst JJ, Hansen HS. The 2-monoacylglycerol moiety of dietary fat appears to be responsible for the fat-induced release of GLP-1 in humans. Am J Clin Nutr. 2015 Sep;102(3):548-55. doi: 10.3945/ajcn.115.106799. Epub 2015 Jul 15.
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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.
Jens J Holst, Professor study chair
Biomedical Sciences, University of Copenhagen
Mette J Mandøe, Student principal investigator
Glostrup Hospital; Biomedical Sciences, University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing Tributyrin, C8-diet oil and Olive oil in people with Type 2 Diabetes, run by Glostrup University Hospital, Copenhagen.
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 3 inclusion and 3 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
plasma GLP-1 (time frame: 2 hours postprandial). The study lists 2 primary outcomes in all. 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 NCT02264951, 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 15 Oct 2014.