Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

Sponsor
University of British Columbia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04309071
Collaborator
Mitacs (Industry), Core-Health Technologies Inc. (Other)
150
1
1
43.9
3.4

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
Actual Study Start Date :
Jan 4, 2019
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Dietary intervention
Salivary insulin responses to a standardized mixed meal

Outcome Measures

Primary Outcome Measures

  1. Saliva insulin area under the curve [Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)]

    The saliva insulin concentration measured by enzyme-linked immunosorbent assay - Area under the curve will be measured using the trapezoidal rule.

  2. Saliva insulin at different time points [Salivary insulin at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)]

    Saliva insulin will be collected and measured by enzyme-linked immunosorbent assay.

Secondary Outcome Measures

  1. Glucose area under the curve [Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)]

    Finger prick glucose concentration measured by glucometer - Area under the curve will be measured using the trapezoidal rule.

  2. Glucose [Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)]

    Finger prick glucose at different time points will be measured by a glucometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of British Columbia Okanagan Kelowna British Columbia Canada V1V 3G1

Sponsors and Collaborators

  • University of British Columbia
  • Mitacs
  • Core-Health Technologies Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jonathan Little, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier:
NCT04309071
Other Study ID Numbers:
  • H18-02699
First Posted:
Mar 16, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jonathan Little, Associate Professor, University of British Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021