Fat-induced Release of GLP-1 in Humans

NCT ID: NCT02264951

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Tributyrin

Intervention Type DIETARY_SUPPLEMENT

a triglyceride containing three C4-acids

Carrot

Intervention Type DIETARY_SUPPLEMENT

mainly water and glucose

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

Group Type ACTIVE_COMPARATOR

C8-diet oil

Intervention Type DIETARY_SUPPLEMENT

a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position

Carrot

Intervention Type DIETARY_SUPPLEMENT

mainly water and glucose

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

Group Type ACTIVE_COMPARATOR

Olive oil

Intervention Type DIETARY_SUPPLEMENT

a triglyceride containing mostly three oleic acids

Carrot

Intervention Type DIETARY_SUPPLEMENT

mainly water and glucose

A meal containing carrot

A meal containing 200 g grated carrot; blood test taken from 0 - 2 hours postprandial

Group Type PLACEBO_COMPARATOR

Carrot

Intervention Type DIETARY_SUPPLEMENT

mainly water and glucose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tributyrin

a triglyceride containing three C4-acids

Intervention Type DIETARY_SUPPLEMENT

C8-diet oil

a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position

Intervention Type DIETARY_SUPPLEMENT

Olive oil

a triglyceride containing mostly three oleic acids

Intervention Type DIETARY_SUPPLEMENT

Carrot

mainly water and glucose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Katrine Bagge Hansen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jens J Holst, Professor

Role: STUDY_CHAIR

Biomedical Sciences, University of Copenhagen

Mette J Mandøe, Student

Role: PRINCIPAL_INVESTIGATOR

Glostrup Hospital; Biomedical Sciences, University of Copenhagen

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26178726 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SFAS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Peripheral Metabolic Effects of Ghrelin
NCT00771940 COMPLETED PHASE1
Triheptanoin in Mc Ardle
NCT02919631 COMPLETED PHASE2