Detection of Salivary Insulin Following Meals

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Behavioral: Low-carbohydrate meal; Behavioral: High-carbohydrate meal

• Registration Number: NCT02699203
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-04
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low-carbohydrate meal	Low-carbohydrate meal	Low carbohydrate breakfast meal consisting of eggs and avocado.
High-carbohydrate meal	High-carbohydrate meal	High carbohydrate breakfast meal consisting of oatmeal and berries.

Primary Outcome Measures

Name	Time	Method
Peak plasma insulin level	0-120 minutes	Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of British Columbia, Okanagan.; 🇨🇦 Kelowna, British Columbia, Canada