Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

NCT ID: NCT04309071

Last Updated: 2021-09-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-04

Study Completion Date

2022-09-30

Brief Summary

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Recent evidence suggests that hyperinsulinemia (i.e., elevated insulin levels) is the primary causative factor in obesity. Insulin promotes fat storage and prevents fat breakdown, suggesting that weight loss would be optimized if insulin levels are managed and kept low. Understanding how different foods impact insulin levels could therefore aid in personalized weight loss (or weight maintenance) advice. It has been shown that salivary insulin can track plasma insulin following different meals and can delineate between lean and obese people. Thus, it was suggested that salivary insulin could be a potential surrogate for plasma insulin. The purpose of this study is to measure fasting saliva insulin, and salivary insulin responses to a standardized meal tolerance test in individuals with different body mass index (BMI).

Detailed Description

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Conditions

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Diet Modification Insulin Resistance Hyperinsulinemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Salivary insulin responses to mixed meal tolerance test

Saliva samples and finger prick glucose will be collected after at least 4 hours of fasting and then at 60 and 90 minutes following ingestion of a standardized meal tolerance test.

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type OTHER

Salivary insulin responses to a standardized mixed meal

Interventions

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Dietary intervention

Salivary insulin responses to a standardized mixed meal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* non-smoker
* have a body mass index greater than 18.5 kg/m2
* have not been diagnosed with type 2 diabetes or other medical conditions affecting glucose or insulin levels

Exclusion Criteria

* You have been. diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) or any other diagnosed chronic condition that may impact your glucose or insulin levels or the outcomes of this study.
* You take any medication which may affect your glucose and insulin level
* Unable to travel to make your testing appointments.
* Unable to consume the meal tolerance test drink/shake and/or provide finger stick glucose or saliva samples for the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mitacs

INDUSTRY

Sponsor Role collaborator

Core-Health Technologies Inc.

UNKNOWN

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Little

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia Okanagan

Kelowna, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Jonathan Little, PhD

Role: primary

2508079876

Role: backup

2508079876

Other Identifiers

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H18-02699

Identifier Type: -

Identifier Source: org_study_id

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