Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
Primary Purpose
Diet Modification, Insulin Resistance, Hyperinsulinemia
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional basic science trial for Diet Modification focused on measuring Salivary insulin
Eligibility Criteria
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.
Sites / Locations
- University of British Columbia OkanaganRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Salivary insulin responses to mixed meal tolerance test
Arm Description
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.
Outcomes
Primary Outcome Measures
Saliva insulin area under the curve
The saliva insulin concentration measured by enzyme-linked immunosorbent assay - Area under the curve will be measured using the trapezoidal rule.
Saliva insulin at different time points
Saliva insulin will be collected and measured by enzyme-linked immunosorbent assay.
Secondary Outcome Measures
Glucose area under the curve
Finger prick glucose concentration measured by glucometer - Area under the curve will be measured using the trapezoidal rule.
Glucose
Finger prick glucose at different time points will be measured by a glucometer.
Full Information
NCT ID
NCT04309071
First Posted
March 11, 2020
Last Updated
September 27, 2021
Sponsor
University of British Columbia
Collaborators
Mitacs, Core-Health Technologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04309071
Brief Title
Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
Official Title
Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Mitacs, Core-Health Technologies Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Modification, Insulin Resistance, Hyperinsulinemia
Keywords
Salivary insulin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Salivary insulin responses to mixed meal tolerance test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
Salivary insulin responses to a standardized mixed meal
Primary Outcome Measure Information:
Title
Saliva insulin area under the curve
Description
The saliva insulin concentration measured by enzyme-linked immunosorbent assay - Area under the curve will be measured using the trapezoidal rule.
Time Frame
Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
Title
Saliva insulin at different time points
Description
Saliva insulin will be collected and measured by enzyme-linked immunosorbent assay.
Time Frame
Salivary insulin at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
Secondary Outcome Measure Information:
Title
Glucose area under the curve
Description
Finger prick glucose concentration measured by glucometer - Area under the curve will be measured using the trapezoidal rule.
Time Frame
Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
Title
Glucose
Description
Finger prick glucose at different time points will be measured by a glucometer.
Time Frame
Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of British Columbia Okanagan
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 3G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Little, PhD
Phone
2508079876
Email
jonathan.little@ubc.ca
Phone
2508079876
Email
jonathan.little@ubc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
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