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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04309071
Other study ID # H18-02699
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 4, 2019
Est. completion date September 2022

Study information

Verified date September 2021
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Canada University of British Columbia Okanagan Kelowna British Columbia

Sponsors (3)

Lead Sponsor Collaborator
University of British Columbia Core-Health Technologies Inc., Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
Primary Saliva insulin at different time points Saliva insulin will be collected and measured by enzyme-linked immunosorbent assay. Salivary insulin at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
Secondary Glucose area under the curve Finger prick glucose concentration measured by glucometer - Area under the curve will be measured using the trapezoidal rule. Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
Secondary Glucose Finger prick glucose at different time points will be measured by a glucometer. Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
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