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Detection of Salivary Insulin Following Meals

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02699203
Enrollment
16
Registered
2016-03-04
Start date
2015-12-31
Completion date
2016-07-01
Last updated
2017-03-17

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

Conditions

Insulin Resistance

Brief 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.

Detailed 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.

Interventions

BEHAVIORALHigh-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.

BEHAVIORALLow-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.

Sponsors

Mitacs
CollaboratorINDUSTRY
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peak plasma insulin level0-120 minutesPeak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.

Secondary

MeasureTime frameDescription
Relationship between peak saliva and peak plasma insulin0-120 minutesCorrelation of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.
Timing of peak saliva and peak plasma insulin0-120 minutesTiming of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.
Plasma insulin area under the curve0-120 minutesArea under the curve for plasma insulin in high carbohydrate versus low carbohydrate arm.
Peak saliva insulin level0-120 minutesPeak salivary insulin in high carbohydrate versus low carbohydrate arm
Saliva insulin area under the curve0-120 minutesArea under the curve for salivary insulin in high carbohydrate versus low carbohydrate arm
Relationship between saliva insulin area under the curve and plasma insulin area under the curve0-120 minutesCorrelation between area under the curve for plasma and saliva insulin in high carbohydrate versus low carbohydrate arm.

Countries

Canada

Outcome results

None listed

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