AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

David Jenkins, MD, PhD contact

416-867-7475

david.jenkins@utoronto.ca

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.

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 groups in NCT04910828
Study groupRoleWhat they receive
Common foods of varying glycemic indicesExperimentalCommon 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.

  1. Heart Rate (pulse)

    Heart Rate (pulse)

    Measured: 2 hours following consumption of food

  2. 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.

  1. First posted2 Jun 2021
  2. Study start1 Jun 2021 (estimated)
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in