Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

Not Applicable

• Conditions: Diet Modification; Insulin Resistance; Hyperinsulinemia
• Interventions: Other: Dietary intervention

• Registration Number: NCT04309071
• Lead Sponsor: University of British Columbia

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-04
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2022-06-01
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salivary insulin responses to mixed meal tolerance test	Dietary intervention	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of British Columbia Okanagan; 🇨🇦 Kelowna, British Columbia, Canada