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CompletedNCT02264951Updated Oct 15, 2014

Fat-induced Release of GLP-1 in Humans

An interventional study of Tributyrin and C8-diet oil in Type 2 Diabetes, sponsored by Glostrup University Hospital, Copenhagen. Completed. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by Glostrup University Hospital, Copenhagen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Short fatty acids
  • 2-oleoyl glycerol
  • GLP-1 secretion
  • C8-diet oil
  • GIP secretion
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 12 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Glostrup University Hospital, Copenhagen is the lead sponsor of 106 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Caucasian healthy male subjects
  • Body mass index (BMI) 19 to 25 kg/m2
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Anaemia
  • Diabetes mellitus
  • Gastrointestinal diseases or operations interacting with intestinal absorption
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
12 participants (actual)

Study arms

  • 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

    Dietary Supplement: Tributyrin · Dietary Supplement: Carrot

  • 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

    Dietary Supplement: C8-diet oil · Dietary Supplement: Carrot

  • 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

    Dietary Supplement: Olive oil · Dietary Supplement: Carrot

  • Placebo comparator
    A meal containing carrot

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

    Dietary Supplement: Carrot

Interventions

  • Dietary supplementTributyrin

    a triglyceride containing three C4-acids

  • Dietary supplementC8-diet oil

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

  • Dietary supplementOlive oil

    a triglyceride containing mostly three oleic acids

  • Dietary supplementCarrot

    mainly water and glucose

06

What researchers measure

Primary outcomes

  1. plasma GLP-1

    Time frame: 2 hours postprandial

  2. plasma GIP

    Time frame: 2 hours postprandial

Secondary outcomes

  1. plasma insulin

    Time frame: 2 hours postprandial

  2. plasma PYY

    Time frame: 2 hours postprandial

  3. plasma glucose

    Time frame: 2 hours postprandial

  4. plasma neurotensin

    Time frame: 2 hour postprandial

  5. plasma CCK

    Time frame: 2 hour postprandial

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02264951
Responsible party
Katrine Bagge Hansen (MD, PhD, Glostrup University Hospital, Copenhagen) — Principal investigator
First posted
Oct 15, 2014
Start date
Oct 2013
Primary completion
Dec 2013
Completion
Feb 2014
Last update
Oct 15, 2014

Study contacts

Jens J Holst, Professor
study chair · Biomedical Sciences, University of Copenhagen
Mette J Mandøe, Student
principal investigator · Glostrup Hospital; Biomedical Sciences, University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Tributyrin · Olive Oil

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