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Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04309071
Enrollment
150
Registered
2020-03-16
Start date
2019-01-04
Completion date
2022-09-30
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Modification, Hyperinsulinemia, Insulin Resistance

Keywords

Salivary insulin

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).

Interventions

OTHERDietary intervention

Salivary insulin responses to a standardized mixed meal

Sponsors

Mitacs
CollaboratorINDUSTRY
Core-Health Technologies Inc.
CollaboratorUNKNOWN
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Saliva insulin area under the curveMeasured 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.
Saliva insulin at different time pointsSalivary 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

MeasureTime frameDescription
Glucose area under the curveMeasured 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.
GlucoseFinger 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026