Detection of Salivary Insulin Following Meals

Insulin Resistance Clinical Trial

Official title:

Detection of Salivary Insulin Following Low Versus High Carbohydrate Meals in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699203
• Other study ID #: H15-02638
• Status: Completed
• Phase: N/A
• First received: February 22, 2016
• Last updated: March 16, 2017
• Start date: December 2015
• Est. completion date: July 1, 2016

Study information

• Verified date: February 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In addition to its role as the major regulator of glucose uptake into peripheral tissues, the hormone insulin is also a primary regulator of fat storage and fat burning of the body. Mechanistic animal studies have shown that high insulin may be the initial trigger for weight gain and be the proximal cause of obesity. There is currently no quick or non-invasive way of measuring insulin as research and clinical techniques require collection of a blood sample followed by a complicated and costly biochemical assay. The investigators will test the hypothesis that insulin levels can be accurately measured in saliva in humans following meals that elicit high and low blood insulin responses. Findings will help determine if insulin can be use as a valid fluid to track insulin changes in humans.

Description:

Lean and obese healthy participants will consume both a high carbohydrate meal and a low carbohydrate meal designed to elicit different insulin responses on two separate occasions. Blood samples and saliva samples will be collected for 2 hours following each meal and insulin will be measured in both plasma and saliva. The relationship between plasma and saliva insulin following the two meals will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index between 18.5-24.9 or over 30.0 kg/m2

Exclusion Criteria:

• Diabetes or other medical conditions affecting glucose or insulin levels

• Smoker

• Competitive athlete

• Vegan or vegetarian

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Behavioral:
• High-carbohydrate meal
Participants will consume a high-carbohydrate low fat meal. The macronutrients content will be 55% carbohydrate, 25% protein and 20% fat providing 400-500 kcal. Between interventions there will be at least a 48-hours washout, where participants are encouraged to return to their baseline dietary habits.
• Low-carbohydrate meal
Participants will consume a low-carbohydrate high fat meal. The macronutrients content will be 10% carbohydrate, 25% protein and 65% fat and will provide 400-500 kcal (matched to the high carbohydrate meal). Between interventions there will be at least a 48-hours washout, where participants are encouraged to return to their baseline dietary habits.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak plasma insulin level	Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.	0-120 minutes
Secondary	Plasma insulin area under the curve	Area under the curve for plasma insulin in high carbohydrate versus low carbohydrate arm.	0-120 minutes
Secondary	Relationship between peak saliva and peak plasma insulin	Correlation of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.	0-120 minutes
Secondary	Timing of peak saliva and peak plasma insulin	Timing of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.	0-120 minutes
Secondary	Relationship between saliva insulin area under the curve and plasma insulin area under the curve	Correlation between area under the curve for plasma and saliva insulin in high carbohydrate versus low carbohydrate arm.	0-120 minutes
Secondary	Peak saliva insulin level	Peak salivary insulin in high carbohydrate versus low carbohydrate arm	0-120 minutes
Secondary	Saliva insulin area under the curve	Area under the curve for salivary insulin in high carbohydrate versus low carbohydrate arm	0-120 minutes