Detection of Salivary Insulin Following Meals

NCT02699203 | Completed

• 1 other identifier: H15-02638
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Peak plasma insulin level

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

  0-120 minutes

Secondary Outcomes (6)

• Plasma insulin area under the curve

  0-120 minutes

• Relationship between peak saliva and peak plasma insulin

  0-120 minutes

• Timing of peak saliva and peak plasma insulin

  0-120 minutes

• Relationship between saliva insulin area under the curve and plasma insulin area under the curve

  0-120 minutes

• Peak saliva insulin level

  0-120 minutes

Study Arms (2)

High-carbohydrate meal

EXPERIMENTAL

High carbohydrate breakfast meal consisting of oatmeal and berries.

Behavioral: High-carbohydrate meal

Low-carbohydrate meal

EXPERIMENTAL

Low carbohydrate breakfast meal consisting of eggs and avocado.

Behavioral: Low-carbohydrate meal

Interventions

High-carbohydrate meal BEHAVIORAL

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.

High-carbohydrate meal

Low-carbohydrate meal BEHAVIORAL

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.

Low-carbohydrate meal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Mitacs: collaborator

Study Sites (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jonathan P Little, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 4, 2016
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 17, 2017

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)