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Effect of Dietary Oils as G-protein-coupled Receptor Agonists on Glucose Tolerance

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ClinicalTrials.gov Identifier: NCT03774095
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Karina Vejrum Sørensen, Odense University Hospital

Brief Summary:

Agonistic activation of fat metabolite responsive G-protein-coupled receptors (GPCR) has been linked to improved glucose metabolism through increased glucose-stimulated-insulin-secreting (GSIS) and incretin release, improved insulin sensitivity and reduced low grade inflammation. In vitro studies have demonstrated that pinolenic acid (20% of pine nut oil) is a potent dual agonist of two GPCRs: free fatty acid receptor-1 (FFA1, formerly GPR40) and free fatty acid receptor-4 (FFA4, formerly GPR120). Moreover, pinolenic acid was able to improve glucose tolerance in mice. G-protein-coupled receptor-119 (GPR119) is known to be activated by the monoacylglycerol: 2-oleoylglycerol (2OG), which is a glycerol molecule attached to oleic acid in the second position. Olive oil contains 61-80% oleic acid, and under digestion 2OG is produced. 2OG has been shown to stimulate GLP-1 release in humans and interestingly, it has recently been suggest that simultaneous activation of GPR119 and FFA1 acts in synergy and enhances enteroendocrine GLP-1 secretion more than the summarized individual agonistic activation. However, this remains to be evaluated in humans. The investigators hypothesize that a combination of pinolenic acid and 2OG administered in delayed release capsules will act in synergy and enhance 1) GLP-1 secretion by stimulating FFA1/FFA4 and GPR119 on enteroendocrine cells causing improved GSIS and increased satiety and 2) enhance GSIS by directly stimulating FFA1 and GPR119 on beta-cells.

Study aim: To investigate the acute effects of pinolenic acid combined with 2OG (olive oil) versus pinolenic acid alone on changes in glucose tolerance, insulin, GLP-1, GIP and ghrelin secretion, appetite and gastrointestinal tolerability in overweight and obese healthy humans.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Dietary Supplement: Hydrolyzed pine nut oil Dietary Supplement: Hydrolyzed pine nut oil and olive oil Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cross-over study of 3 interventions; 1) no oil intake, 2)6g hydrolyzed pine nut oil and 3) combined intake of 3g hydrolyzed pine nut oil and 3g olive oil 30 minutes prior to an 6-hours oral glucose tolerance test (75g glucose).
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Pine Nut and Olive Oil as FFA1/FFA4 and GPR119 Agonists on Glucose Tolerance in Healthy Overweight or Obese Subjects
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
No Intervention: No oil
6-hour oral glucose tolerance test
Active Comparator: Hydrolyzed pine nut oil
6g hydrolyzed pine nut oil in delayed release capsules given 30 min prior to an 6-hour oral glucose tolerance test
Dietary Supplement: Hydrolyzed pine nut oil
Given 30 min prior to oral glucose tolerance test

Active Comparator: Hydrolyzed pine nut oil and olive oil
3g hydrolyzed pine nut oil and 3g olive oil in delayed release capsules given 30 min prior to an 6-hour oral glucose tolerance test
Dietary Supplement: Hydrolyzed pine nut oil and olive oil
Given 30 min prior to oral glucose tolerance test




Primary Outcome Measures :
  1. Glucose [ Time Frame: 6 hours ]
    Glucose area under the curve

  2. Insulin [ Time Frame: 6 hours ]
    Insulin area under the curve

  3. C-peptide [ Time Frame: 6 hours ]
    C-peptide area under the curve

  4. GLP-1 [ Time Frame: 6 hours ]
    GLP-1 area under the curve

  5. GIP [ Time Frame: 6 hours ]
    GIP area under the curve

  6. Ghrelin [ Time Frame: 6 hours ]
    Ghrelin area under the curve

  7. Appetite [ Time Frame: 6 hours ]
    Appetite is measured by the use of Visual analog scales. Respondents specify their level of agreement to a statement on hunger, satiety, fullness, prospective food consumption and thirst by indicating a position along a continuous 100 mm line between two end-points (0 and 100 mm) which represent the extreme feelings related to the statement. In example: How hungry do you feel? 0mm represents: Not hungry at all and 100 mm represents: I have never been hungrier.

  8. Gastrointestinal tolerability [ Time Frame: 24 hours ]
    Gastrointestinal tolerability is measured by the use of Visual analog scales. Respondents specify their level of nausea, flatulence, abdominal pain, diarrhea and constipation by indicating a position along a continuous 100 mm line between two end-points (0 and 100 mm) which represent the extreme feelings related to the symptom in question. In example: Have you been constipated? 0mm represents: No,not at all and 100 mm represents: Yes, severely.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: body mass index (BMI) of 27.5-40 kg/m2, normal glucose tolerance (two hours OGTT plasma glucose ≤ 7.8 mmol/l), normal blood pressure and normal screening blood samples (kidney and liver function, lipids and hematology) and written informed consent -

Exclusion Criteria:any chronic disease including past gastrointestinal diseases or gastrointestinal surgery, first degree relatives with diabetes, food allergies of relevance, need for prescriptive medicine, smoking, body weight changes (> 3 kg within three month prior), intake of dietary supplements (<1 month prior) or any type of restrictive diet for example calorie restriction, vegan diet etc.

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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): NCT03774095


Contacts
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Contact: Karina Sørensen, MSc +45 65413422 karina.vejrum.sorensen@rsyd.dk
Contact: Kurt Højlund, MD +45 65413422

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Karina Sørensen, MSc    26924602      
Contact: Kurt Højlund, MD    +45 65413422      
Sponsors and Collaborators
Karina Vejrum Sørensen
Investigators
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Principal Investigator: Kurt Hø, MD Odense University Hospital/ University of Southern Denmark

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Responsible Party: Karina Vejrum Sørensen, MSc, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03774095     History of Changes
Other Study ID Numbers: PINO 5
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karina Vejrum Sørensen, Odense University Hospital:
incretins
Fat metabolites
Free fatty acid receptors
G-protein-coupled receptors
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Platelet Aggregation Inhibitors