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Completed

NCT Number: NCT02699203

Detection of Salivary Insulin Following Meals

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-carbohydrate meal

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Peak plasma insulin level

    Time frame: 0-120 minutes

    Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.

Secondary outcomes

  1. Plasma insulin area under the curve

    Time frame: 0-120 minutes

    Area under the curve for plasma insulin in high carbohydrate versus low carbohydrate arm.

  2. Relationship between peak saliva and peak plasma insulin

    Time frame: 0-120 minutes

    Correlation of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.

  3. Timing of peak saliva and peak plasma insulin

    Time frame: 0-120 minutes

    Timing of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.

  4. Relationship between saliva insulin area under the curve and plasma insulin area under the curve

    Time frame: 0-120 minutes

    Correlation between area under the curve for plasma and saliva insulin in high carbohydrate versus low carbohydrate arm.

  5. Peak saliva insulin level

    Time frame: 0-120 minutes

    Peak salivary insulin in high carbohydrate versus low carbohydrate arm

  6. Saliva insulin area under the curve

    Time frame: 0-120 minutes

    Area under the curve for salivary insulin in high carbohydrate versus low carbohydrate arm

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Mitacs

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2016
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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