Detection of Salivary Insulin Following Meals

Detection of Salivary Insulin Following Low Versus High Carbohydrate Meals in Humans

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance
• Intervention / Treatment: Behavioral: High-carbohydrate meal; Behavioral: Low-carbohydrate meal

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • University of British Columbia, Okanagan.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma insulin level	Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.	0-120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma insulin area under the curve	Area under the curve for plasma insulin in high carbohydrate versus low carbohydrate arm.	0-120 minutes
Relationship between peak saliva and peak plasma insulin	Correlation of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.	0-120 minutes
Timing of peak saliva and peak plasma insulin	Timing of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.	0-120 minutes
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.	0-120 minutes
Peak saliva insulin level	Peak salivary insulin in high carbohydrate versus low carbohydrate arm	0-120 minutes
Saliva insulin area under the curve	Area under the curve for salivary insulin in high carbohydrate versus low carbohydrate arm	0-120 minutes

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Mitacs

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: H15-02638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO