Detection of Salivary Insulin Following Meals

NCT ID: NCT02699203

Last Updated: 2017-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-07-01

Brief Summary

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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

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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.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High-carbohydrate meal

High carbohydrate breakfast meal consisting of oatmeal and berries.

Group Type EXPERIMENTAL

High-carbohydrate meal

Intervention Type 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.

Low-carbohydrate meal

Low carbohydrate breakfast meal consisting of eggs and avocado.

Group Type EXPERIMENTAL

Low-carbohydrate meal

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mitacs

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan P Little, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia, Okanagan.

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H15-02638

Identifier Type: -

Identifier Source: org_study_id

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