Insulin ResistanceNCT02699203
Detection of Salivary Insulin Following Meals
A study testing High-carbohydrate meal and Low-carbohydrate meal in people with Insulin Resistance, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- High-carbohydrate meal and Low-carbohydrate meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to 1 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 18.5-24.9 or over 30.0 kg/m2
Who cannot join
- Diabetes or other medical conditions affecting glucose or insulin levels
- Smoker
- Competitive athlete
- Vegan or vegetarian
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Okanagan.
Kelowna, British Columbia, V1V 1V7
About this study
Official title: Detection of Salivary Insulin Following Low Versus High Carbohydrate Meals in Humans
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.
Read the 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.
- Conditions
- Insulin Resistance
- Being tested
- High-carbohydrate meal, Low-carbohydrate meal
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-carbohydrate mealBehavioural
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 mealBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-carbohydrate meal | Experimental | High carbohydrate breakfast meal consisting of oatmeal and berries. Receives: Behavioral: High-carbohydrate meal |
| Low-carbohydrate meal | Experimental | Low carbohydrate breakfast meal consisting of eggs and avocado. Receives: Behavioral: Low-carbohydrate meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma insulin level
Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.
Measured: 0-120 minutes
Secondary outcomes (6)
Plasma insulin area under the curve
Area under the curve for plasma insulin in high carbohydrate versus low carbohydrate arm.
Measured: 0-120 minutes
Relationship between peak saliva and peak plasma insulin
Correlation of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.
Measured: 0-120 minutes
Timing of peak saliva and peak plasma insulin
Timing of peak plasma and peak saliva insulin in high carbohydrate versus low carbohydrate arm.
Measured: 0-120 minutes
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.
Measured: 0-120 minutes
Peak saliva insulin level
Peak salivary insulin in high carbohydrate versus low carbohydrate arm
Measured: 0-120 minutes
Saliva insulin area under the curve
Area under the curve for salivary insulin in high carbohydrate versus low carbohydrate arm
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startDec 2015
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Sponsor
- Investigators
- Jonathan P Little, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699203
- Sponsor's protocol ID
- H15-02638
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2016
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Salivary Insulin Following Low Versus High Carbohydrate Meals in Humans
- ClinicalTrials.gov ID
- NCT02699203
- Acronym / sponsor ID
- H15-02638
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- Dec 2015
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-carbohydrate meal | Experimental | Behavioral: High-carbohydrate mealHigh carbohydrate breakfast meal consisting of oatmeal and berries. |
| Low-carbohydrate meal | Experimental | Behavioral: Low-carbohydrate mealLow carbohydrate breakfast meal consisting of eggs and avocado. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index between 18.5-24.9 or over 30.0 kg/m2
Key exclusion criteria (4 listed)
- Diabetes or other medical conditions affecting glucose or insulin levels
- Smoker
- Competitive athlete
- Vegan or vegetarian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-carbohydrate mealParticipants 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. | Behavioural | High-carbohydrate meal |
| Low-carbohydrate mealParticipants 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. | Behavioural | Low-carbohydrate meal |
Primary outcome
Peak plasma insulin level
Time frame: 0-120 minutes
Peak plasma insulin concentration in high carbohydrate versus low carbohydrate arm.
6 secondary outcomes
Plasma insulin area under the curve
Time frame: 0-120 minutes
Relationship between peak saliva and peak plasma insulin
Time frame: 0-120 minutes
Timing of peak saliva and peak plasma insulin
Time frame: 0-120 minutes
Relationship between saliva insulin area under the curve and plasma insulin area under the curve
Time frame: 0-120 minutes
Peak saliva insulin level
Time frame: 0-120 minutes
Saliva insulin area under the curve
Time frame: 0-120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan P Little, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-carbohydrate meal and Low-carbohydrate meal in people with Insulin Resistance, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma insulin level (time frame: 0-120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.