Post-prandial Glucose ResponseNCT02552823
Effects of Peas on Blood Glucose Control
A study testing Group1 and Group2 in people with Post-prandial Glucose Response, run by St. Boniface Hospital at 1 site in Canada.
Trial summary
Diabetes is one of the most common chronic diseases affecting Canadians (PHAC, 2011). Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes (CDA, 2013). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-prandial Glucose Response
- What is being tested?
- Group1 and Group2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 16 Oct 2015to Jan 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy male or female, between the age of 18-40 years;
- Body mass index (BMI) 18.5-34.5 kg/m2;
- HbA1c <6.0%;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study.
Who cannot join
- Pregnant or lactating;
- Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L or use of insulin or oral medication to control blood sugar;
- Medical history of cardiovascular disease
- Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
- Fasting plasma total cholesterol >7.8 mmol/L;
- Fasting plasma HDL <0.9 mmol/L;
Show all 25Show fewer
- Fasting plasma LDL >5.0 mmol/L;
- Fasting plasma triglycerides >2.3 mmol/L;
- A change in blood glucose concentration less than 1 mmol/L between baseline and 30 minutes after consumption of white bread at visit 1;
- Maximum blood glucose concentration occurs after 60 minutes after consumption of white bread at visit 1;
- Major surgery within the last 3 months;
- Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
- Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
- Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
- Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use with the past 6 weeks;
- Active treatment for any type of cancer within 1 year prior to study start;
- Other medical, psychiatric, or behavioral factors that in the judgment of the principal Investigator may interfere with study participation or the ability to follow the intervention protocol;
- Shift worker;
- Tobacco use current or within the last 3 months;
- Allergies to peas;
- Aversion or unwillingness to eat study foods;
- Consuming >4 servings of pulses per week;
- Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycemia;
- Participation in another clinical trial, current or in the past 4 weeks;
- Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.
Trial locations and contacts
1 site in 1 country.
Canada1 site
I. H. Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas on Post-prandial Glucose Response in Healthy Adults
Diabetes is one of the most common chronic diseases affecting Canadians (PHAC, 2011). Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes (CDA, 2013). In this context, the presence of fibre in carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose response (PPGR). Peas are high in fibre and protein and show great potential as a functional food. A health claim for PPGR would increase market demand for peas, and help those who want to limit the rise in blood sugar after a meal choose products to meet their goals, but there are several gaps in the literature that need to be filled before a submission to Health Canada can be successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin response; 3) test varieties of peas that that currently available on the market; 4) test whole/split peas (not fractions or isolates); 5) compare peas to appropriate starchy reference food (rice or potato). The proposed study design will address all of these gaps in the current literature and take into consideration Health Canada's guidance document for health claims related to the reduction in PPGR, which sets out the criteria by which the validity of such claims will be assessed.
Specific objectives
- To determine the effect of 3 common market classes of peas on PPGR and insulin response in a cross-over, randomized, controlled clinical trial.
- To assess the effect of 3 common market classes of peas on appetite-related sensations using visual analog scales.
- To demonstrate whether the test and reference products were liked or disliked similarly by participants.
- To assess any gastrointestinal side effects from eating the test products
Read the detailed description
A randomized, controlled, cross-over study designed to examine the PPGR to peas will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. The study will be divided into 2 groups of 24 healthy volunteers each. In Group 1, eligible participants who have provided consent will be asked to attend 6 clinic visits in a fasted state. Participants will be given white bread at their first and last visits, peas with rice at 3 visits and rice at 1 visit. At each visit participants will provide 7 blood samples via finger poke, 6 questionnaires about their appetite and a questionnaire about the acceptability of the test food. Each visit will last approximately 2.5h and be separated by 3-10 days. Group 2 will undergo the exact same study procedures as group 1, but rice will be replaced with potato.
- Conditions
- Post-prandial Glucose Response
- Being tested
- Group1, Group2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group1Other
Also called Peas with Rice
Group2Other
Also called Peas with potato
| Study group | Role | What they receive |
|---|---|---|
| White bread 1 | Placebo comparator | Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant Receives: Other: Group1; Other: Group2 |
| Pea variety 1 with rice | Experimental | Group 1,Visit 2-5 Pea variety 1 with rice (25g available carbohydrate of each) given as breakfast to fasting participants Receives: Other: Group1 |
| Pea variety 2 with rice | Experimental | Group 1, Visit 2-5 Pea variety 2 with rice (25g available carbohydrate of each) given as breakfast to fasting participants Receives: Other: Group1 |
| Pea variety 3 with rice | Experimental | Group 1, Visit 2-5 Pea variety 3 with rice (25g available carbohydrate of each) given as breakfast to fasting participants Receives: Other: Group1 |
| Rice | Experimental | Group 1, Visit 2-5 Rice (equal to 50g available carbohydrate) given as breakfast to fasting participants Receives: Other: Group1 |
| White bread 2 | Placebo comparator | Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant Receives: Other: Group1; Other: Group2 |
| Pea variety 1 with potato | Experimental | Group 2, Visit 2-5 Pea variety 1 with potato (25g available carbohydrate of each) given as breakfast to fasting participants Receives: Other: Group2 |
| Pea variety 2 with potato | Experimental | Group 2, Visit 2-5 Pea variety 2 with potato (25g available carbohydrate of each) given as breakfast to fasting participants Receives: Other: Group2 |
| Pea variety 3 with potato | Experimental | Group 2, Visit 2-5 Pea variety 3 with potato (25g available carbohydrate of each) given as breakfast to fasting participants Receives: Other: Group2 |
| Potato | Experimental | Group2, Visit 2-5 Potato (equal to 50g available carbohydrate) given as breakfast to fasting participants Receives: Other: Group2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose
samples collected to test glucose at fasting and at 15,30,45,60,90 and 120 minutes after the first bite of the test product
Measured: up to 2 hours following a meal
Postprandial blood insulin
samples collected to test insulin at fasting and at 15,30,45,60,90 and 120 minutes after the first bite of the test product
Measured: up to 2 hours following a meal
Secondary outcomes (3)
Hunger (Visual analogue scales)
Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes
Measured: up to 2 hours following a meal
Fullness (Visual analogue scales)
Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes
Measured: up to 2 hours following a meal
Desire to eat (Visual analogue scales)
Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes
Measured: up to 2 hours following a meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start16 Oct 2015
- Primary completion14 Aug 2017
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post-prandial Glucose ResponseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Dr. Heather Blewett, St. Boniface Hospital
- Investigators
- Heather J Blewett, PhD, Principal investigator, Agriculture and Agri-Food Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552823
- Sponsor's protocol ID
- H29
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2015
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Hamberg O, Rumessen JJ, Gudmand-Hoyer E. Blood glucose response to pea fiber: comparisons with sugar beet fiber and wheat bran. Am J Clin Nutr. 1989 Aug;50(2):324-8. doi: 10.1093/ajcn/50.2.324.
PubMed 2547300Marinangeli CP, Jones PJ. Chronic intake of fractionated yellow pea flour reduces postprandial energy expenditure and carbohydrate oxidation. J Med Food. 2011 Dec;14(12):1654-62. doi: 10.1089/jmf.2010.0255.
PubMed 22145774Marinangeli CP, Kassis AN, Jones PJ. Glycemic responses and sensory characteristics of whole yellow pea flour added to novel functional foods. J Food Sci. 2009 Nov-Dec;74(9):S385-9. doi: 10.1111/j.1750-3841.2009.01347.x.
PubMed 20492127Mollard RC, Wong CL, Luhovyy BL, Cho F, Anderson GH. Second-meal effects of pulses on blood glucose and subjective appetite following a standardized meal 2 h later. Appl Physiol Nutr Metab. 2014 Jul;39(7):849-51. doi: 10.1139/apnm-2013-0523. Epub 2014 May 5.
PubMed 24797207Mollard RC, Zykus A, Luhovyy BL, Nunez MF, Wong CL, Anderson GH. The acute effects of a pulse-containing meal on glycaemic responses and measures of satiety and satiation within and at a later meal. Br J Nutr. 2012 Aug;108(3):509-17. doi: 10.1017/S0007114511005836. Epub 2011 Nov 7.
PubMed 22054112Mollard RC, Wong CL, Luhovyy BL, Anderson GH. First and second meal effects of pulses on blood glucose, appetite, and food intake at a later meal. Appl Physiol Nutr Metab. 2011 Oct;36(5):634-42. doi: 10.1139/h11-071. Epub 2011 Sep 29.
PubMed 21957874Schafer G, Schenk U, Ritzel U, Ramadori G, Leonhardt U. Comparison of the effects of dried peas with those of potatoes in mixed meals on postprandial glucose and insulin concentrations in patients with type 2 diabetes. Am J Clin Nutr. 2003 Jul;78(1):99-103. doi: 10.1093/ajcn/78.1.99.
PubMed 12816777Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
PubMed 19526214
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas on Post-prandial Glucose Response in Healthy Adults
- ClinicalTrials.gov ID
- NCT02552823
- Acronym / sponsor ID
- H29
- Conditions
- Post-prandial Glucose Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- 16 Oct 2015 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 17 Sep 2015 (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.
Diabetes is one of the most common chronic diseases affecting Canadians (PHAC, 2011). Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes (CDA, 2013). In this context, the presence of fibre in carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose response (PPGR). Peas are high in fibre and protein and show great potential as a functional food. A health claim for PPGR would increase market demand for peas, and help those who want to limit the rise in blood sugar after a meal choose products to meet their goals, but there are several gaps in the literature that need to be filled before a submission to Health Canada can be successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin response; 3) test varieties of peas that that currently available on the market; 4) test whole/split peas (not fractions or isolates); 5) compare peas to appropriate starchy reference food (rice or potato). The proposed study design will address all of these gaps in the current literature and take into consideration Health Canada's guidance document for health claims related to the reduction in PPGR, which sets out the criteria by which the validity of such claims will be assessed.
Specific objectives
- To determine the effect of 3 common market classes of peas on PPGR and insulin response in a cross-over, randomized, controlled clinical trial.
- To assess the effect of 3 common market classes of peas on appetite-related sensations using visual analog scales.
- To demonstrate whether the test and reference products were liked or disliked similarly by participants.
- To assess any gastrointestinal side effects from eating the test products
Detailed description
A randomized, controlled, cross-over study designed to examine the PPGR to peas will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. The study will be divided into 2 groups of 24 healthy volunteers each. In Group 1, eligible participants who have provided consent will be asked to attend 6 clinic visits in a fasted state. Participants will be given white bread at their first and last visits, peas with rice at 3 visits and rice at 1 visit. At each visit participants will provide 7 blood samples via finger poke, 6 questionnaires about their appetite and a questionnaire about the acceptability of the test food. Each visit will last approximately 2.5h and be separated by 3-10 days. Group 2 will undergo the exact same study procedures as group 1, but rice will be replaced with potato.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| White bread 1 | Placebo comparator | Other: Group1, Other: Group2Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant |
| Pea variety 1 with rice | Experimental | Other: Group1Group 1,Visit 2-5 Pea variety 1 with rice (25g available carbohydrate of each) given as breakfast to fasting participants |
| Pea variety 2 with rice | Experimental | Other: Group1Group 1, Visit 2-5 Pea variety 2 with rice (25g available carbohydrate of each) given as breakfast to fasting participants |
| Pea variety 3 with rice | Experimental | Other: Group1Group 1, Visit 2-5 Pea variety 3 with rice (25g available carbohydrate of each) given as breakfast to fasting participants |
| Rice | Experimental | Other: Group1Group 1, Visit 2-5 Rice (equal to 50g available carbohydrate) given as breakfast to fasting participants |
| White bread 2 | Placebo comparator | Other: Group1, Other: Group2Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant |
| Pea variety 1 with potato | Experimental | Other: Group2Group 2, Visit 2-5 Pea variety 1 with potato (25g available carbohydrate of each) given as breakfast to fasting participants |
| Pea variety 2 with potato | Experimental | Other: Group2Group 2, Visit 2-5 Pea variety 2 with potato (25g available carbohydrate of each) given as breakfast to fasting participants |
| Pea variety 3 with potato | Experimental | Other: Group2Group 2, Visit 2-5 Pea variety 3 with potato (25g available carbohydrate of each) given as breakfast to fasting participants |
| Potato | Experimental | Other: Group2Group2, Visit 2-5 Potato (equal to 50g available carbohydrate) given as breakfast to fasting participants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Generally healthy male or female, between the age of 18-40 years;
- Body mass index (BMI) 18.5-34.5 kg/m2;
- HbA1c <6.0%;
- Willing to provide informed consent;
- Willing/able to comply with the requirements of the study.
Key exclusion criteria (25 listed)
- Pregnant or lactating;
- Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L or use of insulin or oral medication to control blood sugar;
- Medical history of cardiovascular disease
- Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
- Fasting plasma total cholesterol >7.8 mmol/L;
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 |
|---|---|---|
| Group1Also: Peas with Rice | Other | Pea variety 1 with rice, Pea variety 2 with rice, Pea variety 3 with rice, Rice, White bread 1, White bread 2 |
| Group2Also: Peas with potato | Other | Pea variety 1 with potato, Pea variety 2 with potato, Pea variety 3 with potato, Potato, White bread 1, White bread 2 |
Primary outcome
Postprandial blood glucose
Time frame: up to 2 hours following a meal
samples collected to test glucose at fasting and at 15,30,45,60,90 and 120 minutes after the first bite of the test product
Postprandial blood insulin
Time frame: up to 2 hours following a meal
samples collected to test insulin at fasting and at 15,30,45,60,90 and 120 minutes after the first bite of the test product
3 secondary outcomes
Hunger (Visual analogue scales)
Time frame: up to 2 hours following a meal
Fullness (Visual analogue scales)
Time frame: up to 2 hours following a meal
Desire to eat (Visual analogue scales)
Time frame: up to 2 hours following a meal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 2547300Hamberg O, Rumessen JJ, Gudmand-Hoyer E. Blood glucose response to pea fiber: comparisons with sugar beet fiber and wheat bran. Am J Clin Nutr. 1989 Aug;50(2):324-8. doi: 10.1093/ajcn/50.2.324.
- Background: PubMed 22145774Marinangeli CP, Jones PJ. Chronic intake of fractionated yellow pea flour reduces postprandial energy expenditure and carbohydrate oxidation. J Med Food. 2011 Dec;14(12):1654-62. doi: 10.1089/jmf.2010.0255.
- Background: PubMed 20492127Marinangeli CP, Kassis AN, Jones PJ. Glycemic responses and sensory characteristics of whole yellow pea flour added to novel functional foods. J Food Sci. 2009 Nov-Dec;74(9):S385-9. doi: 10.1111/j.1750-3841.2009.01347.x.
- Background: PubMed 24797207Mollard RC, Wong CL, Luhovyy BL, Cho F, Anderson GH. Second-meal effects of pulses on blood glucose and subjective appetite following a standardized meal 2 h later. Appl Physiol Nutr Metab. 2014 Jul;39(7):849-51. doi: 10.1139/apnm-2013-0523. Epub 2014 May 5.
- Background: PubMed 22054112Mollard RC, Zykus A, Luhovyy BL, Nunez MF, Wong CL, Anderson GH. The acute effects of a pulse-containing meal on glycaemic responses and measures of satiety and satiation within and at a later meal. Br J Nutr. 2012 Aug;108(3):509-17. doi: 10.1017/S0007114511005836. Epub 2011 Nov 7.
- Background: PubMed 21957874Mollard RC, Wong CL, Luhovyy BL, Anderson GH. First and second meal effects of pulses on blood glucose, appetite, and food intake at a later meal. Appl Physiol Nutr Metab. 2011 Oct;36(5):634-42. doi: 10.1139/h11-071. Epub 2011 Sep 29.
- Background: PubMed 12816777Schafer G, Schenk U, Ritzel U, Ramadori G, Leonhardt U. Comparison of the effects of dried peas with those of potatoes in mixed meals on postprandial glucose and insulin concentrations in patients with type 2 diabetes. Am J Clin Nutr. 2003 Jul;78(1):99-103. doi: 10.1093/ajcn/78.1.99.
- Background: PubMed 19526214Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
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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.
Heather J Blewett, PhD principal investigator
Agriculture and Agri-Food Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group1 and Group2 in people with Post-prandial Glucose Response, run by St. Boniface Hospital 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 5 inclusion and 25 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 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
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?
Postprandial blood glucose (time frame: up to 2 hours following a meal). 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?
On the ClinicalTrials.gov record for NCT02552823, which also lists 8 linked publications.
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 Feb 2024.