NCT02264951

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

October 9, 2014

Last Update Submit

October 9, 2014

Conditions

Type 2 Diabetes

Keywords

Short fatty acids2-oleoyl glycerolGLP-1 secretionC8-diet oilGIP secretion

Outcome Measures

Primary Outcomes (2)

  • plasma GLP-1

    2 hours postprandial

  • plasma GIP

    2 hours postprandial

Secondary Outcomes (5)

  • plasma insulin

    2 hours postprandial

  • plasma PYY

    2 hours postprandial

  • plasma glucose

    2 hours postprandial

  • plasma neurotensin

    2 hour postprandial

  • plasma CCK

    2 hour postprandial

Study Arms (4)

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

Dietary Supplement: TributyrinDietary 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

Dietary Supplement: C8-diet oilDietary 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

Dietary Supplement: Olive oilDietary Supplement: Carrot

A meal containing carrot

PLACEBO COMPARATOR

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

Dietary Supplement: Carrot

Interventions

TributyrinDIETARY_SUPPLEMENT

a triglyceride containing three C4-acids

A meal containing carrot and tributyrin
C8-diet oilDIETARY_SUPPLEMENT

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

A meal containing carrot and C8-diet oil
Olive oilDIETARY_SUPPLEMENT

a triglyceride containing mostly three oleic acids

A meal containing carrot and olive oil
CarrotDIETARY_SUPPLEMENT

mainly water and glucose

A meal containing carrotA meal containing carrot and C8-diet oilA meal containing carrot and olive oilA meal containing carrot and tributyrin

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26178726DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tributyrinOlive Oil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jens J Holst, Professor

    Biomedical Sciences, University of Copenhagen

    STUDY CHAIR

  • Mette J Mandøe, Student

    Glostrup Hospital; Biomedical Sciences, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 15, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10