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Fat-induced Release of GLP-1 in Humans

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ClinicalTrials.gov Identifier: NCT02264951
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Tributyrin Dietary Supplement: C8-diet oil Dietary Supplement: Olive oil Dietary Supplement: Carrot Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Short Fatty Acids-induced Release of GLP-1 in Humans
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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
Dietary Supplement: Tributyrin
a triglyceride containing three C4-acids

Dietary Supplement: Carrot
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
Dietary Supplement: C8-diet oil
a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position

Dietary Supplement: Carrot
mainly water and glucose

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
a triglyceride containing mostly three oleic acids

Dietary Supplement: Carrot
mainly water and glucose

Placebo Comparator: A meal containing carrot
A meal containing 200 g grated carrot; blood test taken from 0 - 2 hours postprandial
Dietary Supplement: Carrot
mainly water and glucose




Primary Outcome Measures :
  1. plasma GLP-1 [ Time Frame: 2 hours postprandial ]
  2. plasma GIP [ Time Frame: 2 hours postprandial ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264951


Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
University of Copenhagen
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katrine Bagge Hansen, MD, PhD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT02264951     History of Changes
Other Study ID Numbers: SFAS
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Keywords provided by Katrine Bagge Hansen, Glostrup University Hospital, Copenhagen:
Short fatty acids
2-oleoyl glycerol
GLP-1 secretion
C8-diet oil
GIP secretion