Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

NCT04309071 | Unknown

• 1 other identifier: H18-02699
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Diet Modification; Insulin Resistance; Hyperinsulinemia

Keywords

Salivary insulin

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Glucose area under the curve

  Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)

• 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)

Study Arms (1)

Salivary insulin responses to mixed meal tolerance test

EXPERIMENTAL

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

Interventions

Dietary intervention OTHER

Salivary insulin responses to a standardized mixed meal

Salivary insulin responses to mixed meal tolerance test

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Hyperinsulinism

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 16, 2020
• Study Start: January 4, 2019
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)