Post-prandial Glycaemic ResponsePEA3NCT03306706
Effect of Peas in Muffins on Blood Glucose and Appetite Control
A study testing Whole pea muffins, Split pea muffins and Wheat muffins in people with Post-prandial Glycaemic Response and Satiety, run by St. Boniface Hospital at 1 site in Canada.
Trial summary
This study is part of a group of studies whose overall goal is to accurately define the physiochemical and structural effects of pea varieties and relate these to blood glucose attenuation and appetite related sensations in healthy human volunteers. 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 Glycaemic Response, Satiety
- What is being tested?
- Whole pea muffins, Split pea muffins and Wheat muffins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2017to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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) 18.5-30.0 kg/m2;
- Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively.
- 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 blood glucose ≥6.1 mmol/L, HbA1c ≥6.0%, 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;
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- Fasting plasma LDL >5.0 mmol/L;
- Fasting plasma triglycerides >2.3 mmol/L;
- 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 within the past 6 weeks;
- Active treatment for any type of cancer within 1 year prior to study start;
- Shift worker (a system of employment where an individual's normal hours of work are in part, outside the period of normal working day; 6am and 8pm);
- Smoking, use of tobacco or a nicotine replacement product (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 glycaemia or appetite;
- 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.
- Physical Activity Level >1.8.
- Restraint score >13 (factor 1) on the Three Factor Eating Questionnaire.
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas in Muffins on Post-prandial Glycaemic Response and Satiety in Healthy Adults.
This study is part of a group of studies whose overall goal is to accurately define the physiochemical and structural effects of pea varieties and relate these to blood glucose attenuation and appetite related sensations in healthy human volunteers.
Read the detailed description
A randomized, controlled, cross-over study designed to examine the postprandial glycaemic response and appetite related sensations to peas in muffins will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. Eligible participants who have provided consent will be asked to attend 4 clinic visits in a fasted state. Participants will be given muffins containing peas at 2 visits and muffins without peas at 2 visits. At each visit participants will provide 7 venous blood samples via indwelling catheter, 7 capillary blood samples via finger poke, 2 urine samples, 5 questionnaires about their appetite and a questionnaire about the acceptability of the products. At the end of each visit, participants will eat pizza ad libitum, and the amount of pizza consumed will be measured to determine if the peas influenced the amount of calories consumed at lunch. Participants will record their food/beverage intake for the rest of the day. Each visit will last approximately 3h and be separated by 3-14 days.
- Conditions
- Post-prandial Glycaemic Response, Satiety
- Being tested
- Whole pea muffins, Split pea muffins, Wheat muffins
- Keywords
- blood sugar, insulin, appetite, peas
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole pea muffinsDietary supplement
2 muffins containing whole peas
Split pea muffinsDietary supplement
2 muffins containing split peas
Wheat muffinsDietary supplement
2 muffins containing wheat
| Study group | Role | What they receive |
|---|---|---|
| whole yellow pea | Experimental | 2 muffins containing 25g available carbohydrate from whole yellow peas. Intervention: Whole pea muffins Receives: Dietary Supplement: Whole pea muffins |
| split yellow pea | Experimental | 2 muffins containing 25g available carbohydrate from split yellow peas. Intervention: Split pea muffins Receives: Dietary Supplement: Split pea muffins |
| wheat-PPGR | Placebo comparator | 2 muffins containing 25g available carbohydrate from wheat flour. Intervention: Wheat muffins Receives: Dietary Supplement: Wheat muffins |
| wheat-satiety | Placebo comparator | 2 muffins containing wheat flour to match the calories in the whole and split pea muffins.
Intervention: Wheat muffins Receives: Dietary Supplement: Wheat muffins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glucose response
iAUC glucose
Measured: 120 min
Post-prandial insulin
iAUC insulin
Measured: 120 min
Secondary outcomes (1)
Appetite ratings
AUC for hunger, fullness, desire to eat and prospective consumption using visual analog scales
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start7 Nov 2017
- Primary completion21 Feb 2019
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Post-prandial Glycaemic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, controlled, cross-over
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, University of Manitoba
- Responsible party
- Principal investigator, Dr. Heather Blewett, St. Boniface Hospital
- Investigators
- Heather Blewett, PhD, Principal investigator, Agriculture and Agri-Food Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306706
- Sponsor's protocol ID
- RRC/2017/1702
- Other IDs
- HS21108 (B2017:106)
- Acronym
- PEA3
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2017
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Public Health Agency of Canada and the Canadian Institute for Health Information. Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian institute for health information. Government of Canada; 2011.
Public Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011
Sievenpiper 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 19526214Hamberg 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 22145774Smith CE, Mollard RC, Luhovyy BL, Anderson GH. The effect of yellow pea protein and fibre on short-term food intake, subjective appetite and glycaemic response in healthy young men. Br J Nutr. 2012 Aug;108 Suppl 1:S74-80. doi: 10.1017/S0007114512000700.
PubMed 22916818Jenkins DJ, Thorne MJ, Camelon K, Jenkins A, Rao AV, Taylor RH, Thompson LU, Kalmusky J, Reichert R, Francis T. Effect of processing on digestibility and the blood glucose response: a study of lentils. Am J Clin Nutr. 1982 Dec;36(6):1093-101. doi: 10.1093/ajcn/36.6.1093.
PubMed 6293296Li H, Song F, Xing J, Tsao R, Liu Z, Liu S. Screening and structural characterization of alpha-glucosidase inhibitors from hawthorn leaf flavonoids extract by ultrafiltration LC-DAD-MS(n) and SORI-CID FTICR MS. J Am Soc Mass Spectrom. 2009 Aug;20(8):1496-503. doi: 10.1016/j.jasms.2009.04.003. Epub 2009 Apr 14.
PubMed 19443236Habtemariam S. A-glucosidase inhibitory activity of kaempferol-3-O-rutinoside. Nat Prod Commun. 2011 Feb;6(2):201-3.
PubMed 21425674Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
PubMed 20122136EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA J. 2012 Mar 21;10(3):2604. doi: 10.2903/j.efsa.2012.2604. eCollection 2012 Mar. No abstract available.
PubMed 42112026Health Canada. Draft guidance document: Satiety health claims on food [Internet].; 2012. Available from: http://www.hc-sc.gc.ca/fn-an/consult/satiety-satiete/document-consultation-eng.php
Ames N, Blewett H, Storsley J, Thandapilly SJ, Zahradka P, Taylor C. A double-blind randomised controlled trial testing the effect of a barley product containing varying amounts and types of fibre on the postprandial glucose response of healthy volunteers. Br J Nutr. 2015 May 14;113(9):1373-83. doi: 10.1017/S0007114515000367. Epub 2015 Apr 8.
PubMed 25850814Johansson G, Westerterp KR. Assessment of the physical activity level with two questions: validation with doubly labeled water. Int J Obes (Lond). 2008 Jun;32(6):1031-3. doi: 10.1038/ijo.2008.42. Epub 2008 Apr 8.
PubMed 18392036Rabiee A, Magruder JT, Grant C, Salas-Carrillo R, Gillette A, DuBois J, Shannon RP, Andersen DK, Elahi D. Accuracy and reliability of the Nova StatStrip(R) glucose meter for real-time blood glucose determinations during glucose clamp studies. J Diabetes Sci Technol. 2010 Sep 1;4(5):1195-201. doi: 10.1177/193229681000400519.
PubMed 20920440
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 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 in Muffins on Post-prandial Glycaemic Response and Satiety in Healthy Adults.
- ClinicalTrials.gov ID
- NCT03306706
- Acronym / sponsor ID
- PEA3 / RRC/2017/1702
- Conditions
- Post-prandial Glycaemic Response, Satiety
- Keywords
- blood sugar, insulin, appetite, peas
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada, University of Manitoba
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 11 Oct 2017 (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.
This study is part of a group of studies whose overall goal is to accurately define the physiochemical and structural effects of pea varieties and relate these to blood glucose attenuation and appetite related sensations in healthy human volunteers.
Detailed description
A randomized, controlled, cross-over study designed to examine the postprandial glycaemic response and appetite related sensations to peas in muffins will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. Eligible participants who have provided consent will be asked to attend 4 clinic visits in a fasted state. Participants will be given muffins containing peas at 2 visits and muffins without peas at 2 visits. At each visit participants will provide 7 venous blood samples via indwelling catheter, 7 capillary blood samples via finger poke, 2 urine samples, 5 questionnaires about their appetite and a questionnaire about the acceptability of the products. At the end of each visit, participants will eat pizza ad libitum, and the amount of pizza consumed will be measured to determine if the peas influenced the amount of calories consumed at lunch. Participants will record their food/beverage intake for the rest of the day. Each visit will last approximately 3h and be separated by 3-14 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- randomized, controlled, cross-over
| Arm | Type | Receives |
|---|---|---|
| whole yellow pea | Experimental | Dietary Supplement: Whole pea muffins2 muffins containing 25g available carbohydrate from whole yellow peas. Intervention: Whole pea muffins |
| split yellow pea | Experimental | Dietary Supplement: Split pea muffins2 muffins containing 25g available carbohydrate from split yellow peas. Intervention: Split pea muffins |
| wheat-PPGR | Placebo comparator | Dietary Supplement: Wheat muffins2 muffins containing 25g available carbohydrate from wheat flour. Intervention: Wheat muffins |
| wheat-satiety | Placebo comparator | Dietary Supplement: Wheat muffins2 muffins containing wheat flour to match the calories in the whole and split pea muffins. Intervention: Wheat muffins |
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) 18.5-30.0 kg/m2;
- Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively.
- 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 blood glucose ≥6.1 mmol/L, HbA1c ≥6.0%, 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 |
|---|---|---|
| Whole pea muffins2 muffins containing whole peas | Dietary supplement | whole yellow pea |
| Split pea muffins2 muffins containing split peas | Dietary supplement | split yellow pea |
| Wheat muffins2 muffins containing wheat | Dietary supplement | wheat-PPGR, wheat-satiety |
Primary outcome
Post-prandial glucose response
Time frame: 120 min
iAUC glucose
Post-prandial insulin
Time frame: 120 min
iAUC insulin
1 secondary outcome
Appetite ratings
Time frame: 120 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- BackgroundPublic Health Agency of Canada and the Canadian Institute for Health Information. Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian institute for health information. Government of Canada; 2011.
- BackgroundPublic Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011
- 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.
- 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 22916818Smith CE, Mollard RC, Luhovyy BL, Anderson GH. The effect of yellow pea protein and fibre on short-term food intake, subjective appetite and glycaemic response in healthy young men. Br J Nutr. 2012 Aug;108 Suppl 1:S74-80. doi: 10.1017/S0007114512000700.
- Background: PubMed 6293296Jenkins DJ, Thorne MJ, Camelon K, Jenkins A, Rao AV, Taylor RH, Thompson LU, Kalmusky J, Reichert R, Francis T. Effect of processing on digestibility and the blood glucose response: a study of lentils. Am J Clin Nutr. 1982 Dec;36(6):1093-101. doi: 10.1093/ajcn/36.6.1093.
- Background: PubMed 19443236Li H, Song F, Xing J, Tsao R, Liu Z, Liu S. Screening and structural characterization of alpha-glucosidase inhibitors from hawthorn leaf flavonoids extract by ultrafiltration LC-DAD-MS(n) and SORI-CID FTICR MS. J Am Soc Mass Spectrom. 2009 Aug;20(8):1496-503. doi: 10.1016/j.jasms.2009.04.003. Epub 2009 Apr 14.
- Background: PubMed 21425674Habtemariam S. A-glucosidase inhibitory activity of kaempferol-3-O-rutinoside. Nat Prod Commun. 2011 Feb;6(2):201-3.
- Background: PubMed 20122136Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
- Background: PubMed 42112026EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA J. 2012 Mar 21;10(3):2604. doi: 10.2903/j.efsa.2012.2604. eCollection 2012 Mar. No abstract available.
- BackgroundHealth Canada. Draft guidance document: Satiety health claims on food [Internet].; 2012. Available from: http://www.hc-sc.gc.ca/fn-an/consult/satiety-satiete/document-consultation-eng.php
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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 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 Whole pea muffins, Split pea muffins and Wheat muffins in people with Post-prandial Glycaemic Response and Satiety, 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
Post-prandial glucose response (time frame: 120 min). 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 NCT03306706, which also lists 17 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 29 Nov 2024.