Carbohydrate IntoleranceNCT03015506
Measuring the Glycemic Index of Pulse Based Breads
A study testing Bread in people with Carbohydrate Intolerance, run by Glycemic Index Laboratories, Inc.
Trial summary
The objective of this study is to determine the glycemic index of 4 pulse-based breads in at least 10 normal healthy human volunteers. Participants will be studied in the morning on 6 separate days after overnight fasts. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbohydrate Intolerance
- What is being tested?
- Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants in good health
Who cannot join
- known history of HIV
- known history of diabetes
- history of hepatitis within the last 3 months
- heart condition requiring hospitalization within 3 months
- use of medications or presence of any condition which in the opinion of the study physician, would increase the risk of harm to the subject or to others, or affect the results of the study.
- participants who cannot or will not comply with experimental procedures or the safety guidelines of Glycemic Index Laboratories, Inc.
About this study
The objective of this study is to determine the glycemic index of 4 pulse-based breads in at least 10 normal healthy human volunteers. Participants will be studied in the morning on 6 separate days after overnight fasts. On the first and last days they will consume a test meal consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over 2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after white bread.
- Conditions
- Carbohydrate Intolerance
- Being tested
- Bread
- Medical subject headings
- Glucose-Galactose Malabsorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreadOther
| Study group | Role | What they receive |
|---|---|---|
| White Bread | Active comparator | Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber). Receives: Other: Bread |
| Pea Bread | Experimental | Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) pea flour. Receives: Other: Bread |
| Green Lentil Bread | Experimental | Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) green lentil flour. Receives: Other: Bread |
| Red Lentil Bread | Experimental | Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) red lentil flour. Receives: Other: Bread |
| Chickpea Bread | Experimental | Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) chickpea flour. Receives: Other: Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Index
Glycemic index is 0.71 times F/WB where F is the incremental area under the blood glucose response curve ignoring area below fasting (AUC) elicited by a pulse bread, and WB is the mean AUC elicited by White Bread. AUC is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat. The mean of the values for each pulse bread in each subject is the glycemic index.
Measured: 120 minutes
Secondary outcomes (3)
Incremental area under the blood glucose response curve
Incremental area under the blood glucose response curve ignoring area below fasting (AUC) is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken about 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat.
Measured: 120 minutes
Peak blood glucose concentration (Cmax)
Cmax is the maximum of the blood glucose concentrations measured at 15, 30, 45, 60, 90 and 120 minutes after consumption of a test meal.
Measured: 120 minutes
Peak rise of blood glucose
The maximum of the blood glucose concentrations measured at 15, 30, 45, 60, 90 and 120 minutes after consumption of a test meal minus the fasting blood glucose concentration.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbohydrate IntoleranceStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycemic Index Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015506
- Sponsor's protocol ID
- 01E91-16-62508
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 28 Apr 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 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Glycemic Index of Pulse Based Breads
- ClinicalTrials.gov ID
- NCT03015506
- Acronym / sponsor ID
- 01E91-16-62508
- Conditions
- Carbohydrate Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Glycemic Index Laboratories, IncIndustry (pharma, biotech, devices)
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Jan 2017 (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.
The objective of this study is to determine the glycemic index of 4 pulse-based breads in at least 10 normal healthy human volunteers. Participants will be studied in the morning on 6 separate days after overnight fasts. On the first and last days they will consume a test meal consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over 2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after white bread.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| White Bread | Active comparator | Other: BreadPortion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber). |
| Pea Bread | Experimental | Other: BreadPortion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) pea flour. |
| Green Lentil Bread | Experimental | Other: BreadPortion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) green lentil flour. |
| Red Lentil Bread | Experimental | Other: BreadPortion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) red lentil flour. |
| Chickpea Bread | Experimental | Other: BreadPortion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) chickpea flour. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants in good health
Key exclusion criteria (6 listed)
- known history of HIV
- known history of diabetes
- history of hepatitis within the last 3 months
- heart condition requiring hospitalization within 3 months
- use of medications or presence of any condition which in the opinion of the study physician, would increase the risk of harm to the subject or to others, or affect the results of 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 |
|---|---|---|
| Bread | Other | Chickpea Bread, Green Lentil Bread, Pea Bread, Red Lentil Bread, White Bread |
Primary outcome
Glycemic Index
Time frame: 120 minutes
Glycemic index is 0.71 times F/WB where F is the incremental area under the blood glucose response curve ignoring area below fasting (AUC) elicited by a pulse bread, and WB is the mean AUC elicited by White Bread. AUC is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat. The mean of the values for each pulse bread in each subject is the glycemic index.
3 secondary outcomes
Incremental area under the blood glucose response curve
Time frame: 120 minutes
Peak blood glucose concentration (Cmax)
Time frame: 120 minutes
Peak rise of blood glucose
Time frame: 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 28 Apr 2017.
- 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.
Thomas MS Wolever, MD, PhD principal investigator
Glycemic Index Laboratories, Inc
Questions about this trial
What is this clinical trial studying?
A study testing Bread in people with Carbohydrate Intolerance, run by Glycemic Index Laboratories, Inc.
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 6 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 28 Apr 2017. 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?
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?
Glycemic Index (time frame: 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 28 Apr 2017.