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Dose-response Effect of Pine Nut Oil as a Dual FFA1 and FFA4 Agonist on Glucose Tolerance in Healthy Humans.

NCT03305367 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-12-13

No results posted yet for this study

Summary

Several free fatty acids receptors (FFARs) have been discovered. These have been implicated in metabolic processes and inflammation. Consequently, these receptors have attracted interest as targets for the treatment of metabolic and inflammatory diseases, including obesity and type 2 diabetes. Two of these FFARs (FFA1, FFA4), which is activated by specific free fatty acids (FFAs), is expressed on enteroendocrine cells, pancreatic beta-cells and adipocytes. They have been linked to 1) increased glucagon-like peptide-1 (GLP-1) secretion and hence the incretin-mediated increase in glucose-stimulated insulin secretion (GSIS) and suppression of glucagon secretion, 2) a direct positive effect on GSIS, 3) reduced inflammation and 4) improved insulin sensitivity. These functions and the abundance of fatty acids in food suggest that FFARs can be considered as nutrient sensing regulators of metabolism. Roux-en-Y gastric bypass (RYGB), frequently results in immediate beneficial effects on glucose metabolism and often complete remission of type 2 diabetes. This may in part be explained by increased GLP-1 levels after surgery. It appears that the effect depends on nutrient delivery directly to the lower parts of the small intestine. It is possible that the RYGB effects are partly due to enteroendocrine stimulation of FFA1 and perhaps FFA4 by direct nutrient delivery, i.e. FFA release in the lower intestines. Pinolenic acid from pine nuts has been shown to be a potent dual FFA1/FFA4 agonist.

Based on these findings the investigators have planned a number of human intervention studies in order to investigate 1) the optimal oral formulation of pine nut oil 2) whether it is possible to mimic the beneficial effects observed after RYGB, 2) if it is possible to increase GLP-1 secretion by stimulating FFA1/FFA4 on enteroendocrine cells causing improved GSIS and increased satiety and 3) enhancement of GSIS by directly stimulating FFA1 on beta-cells.

Conditions

Interventions

DIETARY_SUPPLEMENT

Hydrolyzed pine nut oil

Randomized cros-over intervention of 3 OGTT with no oil, low dose or high dose.

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Kurt Højlund, MD · Department of Endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2017-08-23
Completion
2017-08-23

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305367 on ClinicalTrials.gov