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Detection of Salivary Insulin Following Meals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699203
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Mitacs
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
In addition to its role as the major regulator of glucose uptake into peripheral tissues, the hormone insulin is also a primary regulator of fat storage and fat burning of the body. Mechanistic animal studies have shown that high insulin may be the initial trigger for weight gain and be the proximal cause of obesity. There is currently no quick or non-invasive way of measuring insulin as research and clinical techniques require collection of a blood sample followed by a complicated and costly biochemical assay. The investigators will test the hypothesis that insulin levels can be accurately measured in saliva in humans following meals that elicit high and low blood insulin responses. Findings will help determine if insulin can be use as a valid fluid to track insulin changes in humans.

Condition or disease Intervention/treatment Phase
Insulin Resistance Behavioral: High-carbohydrate meal Behavioral: Low-carbohydrate meal Not Applicable

Detailed Description:
Lean and obese healthy participants will consume both a high carbohydrate meal and a low carbohydrate meal designed to elicit different insulin responses on two separate occasions. Blood samples and saliva samples will be collected for 2 hours following each meal and insulin will be measured in both plasma and saliva. The relationship between plasma and saliva insulin following the two meals will be assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Detection of Salivary Insulin Following Low Versus High Carbohydrate Meals in Humans
Study Start Date : December 2015
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : July 1, 2016

Arm Intervention/treatment
Experimental: High-carbohydrate meal
High carbohydrate breakfast meal consisting of oatmeal and berries.
Behavioral: High-carbohydrate meal
Participants will consume a high-carbohydrate low fat meal. The macronutrients content will be 55% carbohydrate, 25% protein and 20% fat providing 400-500 kcal. Between interventions there will be at least a 48-hours washout, where participants are encouraged to return to their baseline dietary habits.

Experimental: Low-carbohydrate meal
Low carbohydrate breakfast meal consisting of eggs and avocado.
Behavioral: Low-carbohydrate meal
Participants will consume a low-carbohydrate high fat meal. The macronutrients content will be 10% carbohydrate, 25% protein and 65% fat and will provide 400-500 kcal (matched to the high carbohydrate meal). Between interventions there will be at least a 48-hours washout, where participants are encouraged to return to their baseline dietary habits.




Primary Outcome Measures :
  1. Peak plasma insulin level [ Time Frame: 0-120 minutes ]
    Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.


Secondary Outcome Measures :
  1. Plasma insulin area under the curve [ Time Frame: 0-120 minutes ]
    Area under the curve for plasma insulin in high carbohydrate versus low carbohydrate arm.

  2. Relationship between peak saliva and peak plasma insulin [ Time Frame: 0-120 minutes ]
    Correlation of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.

  3. Timing of peak saliva and peak plasma insulin [ Time Frame: 0-120 minutes ]
    Timing of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.

  4. Relationship between saliva insulin area under the curve and plasma insulin area under the curve [ Time Frame: 0-120 minutes ]
    Correlation between area under the curve for plasma and saliva insulin in high carbohydrate versus low carbohydrate arm.

  5. Peak saliva insulin level [ Time Frame: 0-120 minutes ]
    Peak salivary insulin in high carbohydrate versus low carbohydrate arm

  6. Saliva insulin area under the curve [ Time Frame: 0-120 minutes ]
    Area under the curve for salivary insulin in high carbohydrate versus low carbohydrate arm



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index between 18.5-24.9 or over 30.0 kg/m2

Exclusion Criteria:

  • Diabetes or other medical conditions affecting glucose or insulin levels
  • Smoker
  • Competitive athlete
  • Vegan or vegetarian

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): NCT02699203


Locations
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Canada, British Columbia
University of British Columbia, Okanagan.
Kelowna, British Columbia, Canada, V1V 1V7
Sponsors and Collaborators
University of British Columbia
Mitacs
Investigators
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Principal Investigator: Jonathan P Little, PhD University of British Columbia
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02699203    
Other Study ID Numbers: H15-02638
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases