Heart RateNCT04910828
Effect of High and Low Glycemic Index Foods on Post Meal Pulse and Blood Pressure
A study testing Common foods of varying glycemic indices in people with Heart Rate and Blood Pressure, run by University of Toronto.
Trial summary
The aim of this study is to test high and low glycemic index foods in healthy adult volunteers and determine the effects on post meal pulse and blood pressure. Foods will be consumed before 8am after an overnight fast (10-12 hours) over a 10-15 minute period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rate, Blood Pressure
- What is being tested?
- Common foods of varying glycemic indices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 30 Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers
Who cannot join
- Serious health condition preventing participants from eating 50g of "available" carbohydrates as a test breakfast. For example: 1) food intolerances or allergies to common foods; 2) gastrointestinal conditions requiring medical treatment (Crohn's, ulcerative colitis) and a special diet; 3) bariatric surgery.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to test high and low glycemic index foods in healthy adult volunteers and determine the effects on post meal pulse and blood pressure. Foods will be consumed before 8am after an overnight fast (10-12 hours) over a 10-15 minute period. Pulse and BP (where equipment is available) measurements will be taken 6 times at 5 min intervals before eating, and twice every 15 min thereafter for the following 2h. We will recruit between 30 to 40 students and 10 to 20 older adults to assess the effect of age, in cohorts of 10.
Read the detailed description
STUDY OBJECTIVE
The aim of this study is to test high and low glycemic index foods in healthy volunteers and determine the effects on post meal pulse and blood pressure.
METHODS
Participants: 30 to 40 students and 10 to 20 older adults (>60 years) will be recruited.
Inclusion:
-Healthy adult volunteers
Exclusion:
-Serious health condition preventing participants from eating 50g of "available" carbohydrates as a test breakfast. For example: 1) food intolerances or allergies to common foods; 2) gastrointestinal conditions requiring medical treatment (Crohn's, ulcerative colitis) and a special diet; 3) bariatric surgery.
Recruitment Study participants will be recruited from those who have contacted us and showed interest in working with our group as well as colleagues who show interest in this project. The study coordinator will obtain consent by telephone and confirm by email.
Study Design Fifty of the original 65 carbohydrate foods, as used in the 1981 AJCN (American Journal Of Clinical Nutrition) glycemic index paper, that established the first comprehensive values for the glycemic index of foods, will be fed to healthy volunteers as 50g carbohydrate portions as was done for the original GI testing. Foods will be consumed before 8am after an overnight fast (10-12 hours) over a 10-15 minute period. Pulse and BP (where equipment is available) measurements will be taken 6 times at 5 min intervals before eating, and twice every 15 min thereafter for the following 2h. Participants will be asked to test at least 10 (or more as they wish) foods on separate days. The minimum duration for their participation will therefore be 10 days but not necessarily consecutively.
Sample Size We will recruit between 30 to 40 students and 10 to 20 older adults to assess the effect of age, in cohorts of 10, and to have the flexibility for volunteers to do less foods but still have a wide range of foods on which to obtain a tachycardia or hypotension index.
Procedures Prior to starting the study, they will be asked to complete a medical questionnaire sent to them by email and return it to the study coordinator for review. Participants will either come to the Risk Factor Modification Centre at St. Michael's Hospital if pandemic restrictions allow, or will carry out the testing by themselves at home. Tests will be carried out after an overnight fast. Participants will sit quietly for 15 minutes and then repeat pulse (and BP with the Omron or other monitor if available) measurements 6 x at 5 min intervals or until measurements are consistent for 3 consecutive readings.
The test meal breakfast will then be eaten over 10-15 minutes, with 2 further pulse measurements taken at 15 minute intervals for the following 2h after the start of breakfast.
Throughout, participants will be asked to remain seated and emotionally uninvolved with their environment. Pulse can be counted for 30 seconds to ensure concentration (and x by 2 for the minute value). Written work, answering emails etc. can be undertaken providing the timing of pulse measurements does not induce stress. The first 2h are crucial in this respect.
Study Intervention/Breakfasts Participants will be given a list of 10 foods (including white bread to be used as the standard), and their weights and method of preparation. They will acquire these common foods themselves. If they have no scales available, they will portion the foods using common measures and the values with which they will be provided. Cooking instructions will also be provided where necessary. Food portions should be measured out the night before and left in the refrigerator overnight.
Foods will be consumed plain or with a set weight of fat (e.g. butter or margarine) or protein (cottage cheese or tofu). A beverage of their choice (tea or coffee) will also be taken with either cow or soy milk or water. The quantities should be constant across all test breakfasts and the total volume of the beverage should be 300 ml.
Foods A list of foods, portion sizes, preparation instructions and order in which to eat them will be provided prior to the start of the study.
Study test diary form Forms on which to record timing and study details (cooking instructions for lentils, pasta etc.) will be provided for each test.
Scales and measuring jugs Where possible participants should ensure that they have electronic scales with wall plugs that are in gram weights and also jugs with ml volume calibrations.
- Conditions
- Heart Rate, Blood Pressure
- Being tested
- Common foods of varying glycemic indices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common foods of varying glycemic indicesOther
Examples of foods of varying glycemic index to be tested include bread, rice, breakfast cereals, starchy vegetables, legumes, fruit and dairy products.
| Study group | Role | What they receive |
|---|---|---|
| Common foods of varying glycemic indices | Experimental | Common foods of varying glycemic indices Receives: Other: Common foods of varying glycemic indices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (pulse)
Heart Rate (pulse)
Measured: 2 hours following consumption of food
Blood pressure
Blood pressure
Measured: 2 hours following consumption of food
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Jenkins, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910828
- Sponsor's protocol ID
- REB 20-114
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High and Low Glycemic Index Foods on Post Meal Pulse and Blood Pressure
- ClinicalTrials.gov ID
- NCT04910828
- Acronym / sponsor ID
- REB 20-114
- Conditions
- Heart Rate, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 2 Jun 2021 (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.
The aim of this study is to test high and low glycemic index foods in healthy adult volunteers and determine the effects on post meal pulse and blood pressure. Foods will be consumed before 8am after an overnight fast (10-12 hours) over a 10-15 minute period. Pulse and BP (where equipment is available) measurements will be taken 6 times at 5 min intervals before eating, and twice every 15 min thereafter for the following 2h. We will recruit between 30 to 40 students and 10 to 20 older adults to assess the effect of age, in cohorts of 10.
Detailed description
STUDY OBJECTIVE
The aim of this study is to test high and low glycemic index foods in healthy volunteers and determine the effects on post meal pulse and blood pressure.
METHODS
Participants: 30 to 40 students and 10 to 20 older adults (>60 years) will be recruited.
Inclusion:
-Healthy adult volunteers
Exclusion:
-Serious health condition preventing participants from eating 50g of "available" carbohydrates as a test breakfast. For example: 1) food intolerances or allergies to common foods; 2) gastrointestinal conditions requiring medical treatment (Crohn's, ulcerative colitis) and a special diet; 3) bariatric surgery.
Recruitment Study participants will be recruited from those who have contacted us and showed interest in working with our group as well as colleagues who show interest in this project. The study coordinator will obtain consent by telephone and confirm by email.
Study Design Fifty of the original 65 carbohydrate foods, as used in the 1981 AJCN (American Journal Of Clinical Nutrition) glycemic index paper, that established the first comprehensive values for the glycemic index of foods, will be fed to healthy volunteers as 50g carbohydrate portions as was done for the original GI testing. Foods will be consumed before 8am after an overnight fast (10-12 hours) over a 10-15 minute period. Pulse and BP (where equipment is available) measurements will be taken 6 times at 5 min intervals before eating, and twice every 15 min thereafter for the following 2h. Participants will be asked to test at least 10 (or more as they wish) foods on separate days. The minimum duration for their participation will therefore be 10 days but not necessarily consecutively.
Sample Size We will recruit between 30 to 40 students and 10 to 20 older adults to assess the effect of age, in cohorts of 10, and to have the flexibility for volunteers to do less foods but still have a wide range of foods on which to obtain a tachycardia or hypotension index.
Procedures Prior to starting the study, they will be asked to complete a medical questionnaire sent to them by email and return it to the study coordinator for review. Participants will either come to the Risk Factor Modification Centre at St. Michael's Hospital if pandemic restrictions allow, or will carry out the testing by themselves at home. Tests will be carried out after an overnight fast. Participants will sit quietly for 15 minutes and then repeat pulse (and BP with the Omron or other monitor if available) measurements 6 x at 5 min intervals or until measurements are consistent for 3 consecutive readings.
The test meal breakfast will then be eaten over 10-15 minutes, with 2 further pulse measurements taken at 15 minute intervals for the following 2h after the start of breakfast.
Throughout, participants will be asked to remain seated and emotionally uninvolved with their environment. Pulse can be counted for 30 seconds to ensure concentration (and x by 2 for the minute value). Written work, answering emails etc. can be undertaken providing the timing of pulse measurements does not induce stress. The first 2h are crucial in this respect.
Study Intervention/Breakfasts Participants will be given a list of 10 foods (including white bread to be used as the standard), and their weights and method of preparation. They will acquire these common foods themselves. If they have no scales available, they will portion the foods using common measures and the values with which they will be provided. Cooking instructions will also be provided where necessary. Food portions should be measured out the night before and left in the refrigerator overnight.
Foods will be consumed plain or with a set weight of fat (e.g. butter or margarine) or protein (cottage cheese or tofu). A beverage of their choice (tea or coffee) will also be taken with either cow or soy milk or water. The quantities should be constant across all test breakfasts and the total volume of the beverage should be 300 ml.
Foods A list of foods, portion sizes, preparation instructions and order in which to eat them will be provided prior to the start of the study.
Study test diary form Forms on which to record timing and study details (cooking instructions for lentils, pasta etc.) will be provided for each test.
Scales and measuring jugs Where possible participants should ensure that they have electronic scales with wall plugs that are in gram weights and also jugs with ml volume calibrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Common foods of varying glycemic indices | Experimental | Other: Common foods of varying glycemic indicesCommon foods of varying glycemic indices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult volunteers
Key exclusion criteria (1 listed)
- Serious health condition preventing participants from eating 50g of "available" carbohydrates as a test breakfast. For example: 1) food intolerances or allergies to common foods; 2) gastrointestinal conditions requiring medical treatment (Crohn's, ulcerative colitis) and a special diet; 3) bariatric surgery.
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 |
|---|---|---|
| Common foods of varying glycemic indicesExamples of foods of varying glycemic index to be tested include bread, rice, breakfast cereals, starchy vegetables, legumes, fruit and dairy products. | Other | Common foods of varying glycemic indices |
Primary outcome
Heart Rate (pulse)
Time frame: 2 hours following consumption of food
Heart Rate (pulse)
Blood pressure
Time frame: 2 hours following consumption of food
Blood pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Common foods of varying glycemic indices in people with Heart Rate and Blood Pressure, run by University of Toronto.
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 1 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact David Jenkins, MD, PhD (416-867-7475, david.jenkins@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (pulse) (time frame: 2 hours following consumption of food). 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 2 Jun 2021.