Diet ModificationNCT04309071
Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
A study testing Dietary intervention in people with Diet Modification and Insulin Resistance, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification, Insulin Resistance, Hyperinsulinemia
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2019to Sep 2022
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 3G1
Jonathan Little, PhD, 2508079876, jonathan.little@ubc.ca
2508079876, jonathan.little@ubc.ca
About this study
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
- Being tested
- Dietary intervention
- Keywords
- Salivary insulin
- Medical subject headings
- Insulin Resistance, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Salivary insulin responses to a standardized mixed meal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
Measured: 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
Finger prick glucose concentration measured by glucometer - Area under the curve will be measured using the trapezoidal rule.
Measured: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
Glucose
Finger prick glucose at different time points will be measured by a glucometer.
Measured: Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start4 Jan 2019
- Primary completion1 Jun 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, Core-Health Technologies Inc.
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309071
- Sponsor's protocol ID
- H18-02699
- Status last verified
- Sep 2021
- First submitted
- 11 Mar 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
- ClinicalTrials.gov ID
- NCT04309071
- Acronym / sponsor ID
- H18-02699
- Conditions
- Diet Modification, Insulin Resistance, Hyperinsulinemia
- Keywords
- Salivary insulin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Mitacs, Core-Health Technologies Inc.
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 16 Mar 2020 (actual)
- 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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salivary insulin responses to mixed meal tolerance test | Experimental | Other: Dietary interventionSaliva 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Dietary interventionSalivary insulin responses to a standardized mixed meal | Other | Salivary insulin responses to mixed meal tolerance test |
Primary outcome
Saliva insulin area under the curve
Time frame: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
The saliva insulin concentration measured by enzyme-linked immunosorbent assay - Area under the curve will be measured using the trapezoidal rule.
Saliva insulin at different time points
Time frame: Salivary insulin at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
Saliva insulin will be collected and measured by enzyme-linked immunosorbent assay.
2 secondary outcomes
Glucose area under the curve
Time frame: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
Glucose
Time frame: Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Diet Modification and 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 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva insulin area under the curve (time frame: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)). The study lists 2 primary outcomes in all. 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 28 Sep 2021.