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Post-prandial Glycaemic ResponseNCT03506932

Effect of Pea Flour in Bread on Blood Glucose

A study testing Untreated, Heat treated with 0% moisture and Heat treated with 10% moisture in people with Post-prandial Glycaemic Response, run by St. Boniface Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study's overall goal is to investigate methods to improve the acceptability of pulse containing foods that provide a health benefit to consumers. The health benefits we are testing are post-prandial 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
What is being tested?
Untreated, Heat treated with 0% moisture and Heat treated with 10% moisture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
17 Apr 2019to 18 Dec 2019
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) 18.5-30.0 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;
Show all 23Show fewer
  • 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 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN));
  • Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥3 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, and cannabis in any form (within the last 3 months);
  • Allergies to peas or wheat;
  • 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.
  • 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.

Canada1 site

  • I. H. Asper Clinical Research Institute

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Yellow Pea Flour in Bread on Post-prandial Glycaemic Response in Healthy Adults

This study's overall goal is to investigate methods to improve the acceptability of pulse containing foods that provide a health benefit to consumers. The health benefits we are testing are post-prandial 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 post-prandial glycaemic response, metabolism of bioactives and appetite related sensations to 20% incorporation of yellow pea flour (untreated, heat treated with 0% moisture and heat treated with 10% moisture) into bread 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 bread containing 20% yellow pea flour at 3 visits and bread with 100% wheat flour at 1 visit. 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. Each visit will last approximately 3h and be separated by 3-14 days.

Being tested
Untreated, Heat treated with 0% moisture, Heat treated with 10% moisture, Wheat
Keywords
blood sugar, insulin, peas, bread, metabolites
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UntreatedDietary supplement

    Bread made with 20% yellow pea flour that was untreated.

  • Heat treated with 0% moistureDietary supplement

    Bread made with 20% yellow pea flour that was heat treated with 0% moisture.

  • Heat treated with 10% moistureDietary supplement

    Bread made with 20% yellow pea flour that was heat treated with 10% moisture.

  • WheatDietary supplement

    Bread made with 100% wheat

Study groups in NCT03506932
Study groupRoleWhat they receive
UntreatedExperimentalBread containing 20% yellow pea flour.
Receives: Dietary Supplement: Untreated
Heat treated with 0% moistureExperimentalBread containing 20% yellow pea flour.
Receives: Dietary Supplement: Heat treated with 0% moisture
Heat treated with 10% moistureExperimentalBread containing 20% yellow pea flour.
Receives: Dietary Supplement: Heat treated with 10% moisture
WheatActive comparatorBread made with 100% wheat flour
Receives: Dietary Supplement: Wheat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-prandial glucose

    incremental area under the curve (iAUC) for glucose

    Measured: 120 minutes

  2. Post-prandial insulin

    iAUC insulin

    Measured: 120 minutes

Secondary outcomes (2)

  1. Urinary metabolite profile

    Concentration of metabolites in urine

    Measured: 120 minutes

  2. Plasma metabolite profile

    Concentration of metabolites in plasma

    Measured: 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2018
  2. Study start17 Apr 2019
  3. Primary completion18 Dec 2019
  4. Study completion18 Dec 2019

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
Randomised
Intervention model
Crossover
Model description
Randomized, controlled, cross-over study
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03506932
Sponsor's protocol ID
HS21603 (B2018:026)
Other IDs
RRC/2018/1748
Status last verified
Nov 2024
First submitted
13 Apr 2018
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

  • 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 19526214

  • Marinangeli 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 22145774

  • Robinson DS, Wu Z, Domoney C, Casey R. Lipoxygenases and the quality of foods. Food Chem 54:33-43,1995.

  • Rackis JJ, Sessa DJ, Honig DH. Flavor problems of vegetable food proteins. J Am Oil Chem Soc 56(3):262-71,1979.

  • Shariati-Ievari S, Ryland D, Edel A, Nicholson T, Suh M, Aliani M. Sensory and Physicochemical Studies of Thermally Micronized Chickpea (Cicer arietinum) and Green Lentil (Lens culinaris) Flours as Binders in Low-Fat Beef Burgers. J Food Sci. 2016 May;81(5):S1230-42. doi: 10.1111/1750-3841.13273. Epub 2016 Mar 15.

    PubMed 26990186

  • Mitzak, M. 2007. Method for heat treatment of powdery materials (Google Patents).

  • Jenkins 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 6293296

  • Li 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 19443236

  • Habtemariam S. A-glucosidase inhibitory activity of kaempferol-3-O-rutinoside. Nat Prod Commun. 2011 Feb;6(2):201-3.

    PubMed 21425674

  • Blundell 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 20122136

  • EFSA 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 42112026

  • Health 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 25850814

  • Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.

    PubMed 19079901

  • Rabiee 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

Questions about this trial

What is this clinical trial studying?

A study testing Untreated, Heat treated with 0% moisture and Heat treated with 10% moisture in people with Post-prandial Glycaemic 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 23 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 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. 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?

Post-prandial glucose (time frame: 120 minutes). 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 NCT03506932, 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.

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