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Detection of Salivary Insulin Following Meals

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-carbohydrate meal
Low-carbohydrate meal
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of British Columbia, Okanagan.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High-carbohydrate meal

Low-carbohydrate meal

Arm Description

High carbohydrate breakfast meal consisting of oatmeal and berries.

Low carbohydrate breakfast meal consisting of eggs and avocado.

Outcomes

Primary Outcome Measures

Peak plasma insulin level
Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.

Secondary Outcome Measures

Plasma insulin area under the curve
Area under the curve for plasma insulin in high carbohydrate versus low carbohydrate arm.
Relationship between peak saliva and peak plasma insulin
Correlation of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.
Timing of peak saliva and peak plasma insulin
Timing of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.
Relationship between saliva insulin area under the curve and plasma insulin area under the curve
Correlation between area under the curve for plasma and saliva insulin in high carbohydrate versus low carbohydrate arm.
Peak saliva insulin level
Peak salivary insulin in high carbohydrate versus low carbohydrate arm
Saliva insulin area under the curve
Area under the curve for salivary insulin in high carbohydrate versus low carbohydrate arm

Full Information

First Posted
February 22, 2016
Last Updated
March 16, 2017
Sponsor
University of British Columbia
Collaborators
Mitacs
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1. Study Identification

Unique Protocol Identification Number
NCT02699203
Brief Title
Detection of Salivary Insulin Following Meals
Official Title
Detection of Salivary Insulin Following Low Versus High Carbohydrate Meals in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
July 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Mitacs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-carbohydrate meal
Arm Type
Experimental
Arm Description
High carbohydrate breakfast meal consisting of oatmeal and berries.
Arm Title
Low-carbohydrate meal
Arm Type
Experimental
Arm Description
Low carbohydrate breakfast meal consisting of eggs and avocado.
Intervention Type
Behavioral
Intervention Name(s)
High-carbohydrate meal
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-carbohydrate meal
Intervention Description
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 Measure Information:
Title
Peak plasma insulin level
Description
Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.
Time Frame
0-120 minutes
Secondary Outcome Measure Information:
Title
Plasma insulin area under the curve
Description
Area under the curve for plasma insulin in high carbohydrate versus low carbohydrate arm.
Time Frame
0-120 minutes
Title
Relationship between peak saliva and peak plasma insulin
Description
Correlation of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.
Time Frame
0-120 minutes
Title
Timing of peak saliva and peak plasma insulin
Description
Timing of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.
Time Frame
0-120 minutes
Title
Relationship between saliva insulin area under the curve and plasma insulin area under the curve
Description
Correlation between area under the curve for plasma and saliva insulin in high carbohydrate versus low carbohydrate arm.
Time Frame
0-120 minutes
Title
Peak saliva insulin level
Description
Peak salivary insulin in high carbohydrate versus low carbohydrate arm
Time Frame
0-120 minutes
Title
Saliva insulin area under the curve
Description
Area under the curve for salivary insulin in high carbohydrate versus low carbohydrate arm
Time Frame
0-120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Little, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia, Okanagan.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Detection of Salivary Insulin Following Meals

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