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Active, not recruitingNCT03306927PEA5Updated Nov 29, 2024

Effect of Peas in Chili on Blood Glucose and Appetite Control

An interventional study of Whole yellow pea chili and Split yellow pea chili in Post-prandial Glycaemic Response and Satiety, sponsored by St. Boniface Hospital. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by St. Boniface Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 the detailed description

A randomized, controlled, cross-over study designed to examine the PPGR and appetite related sensations to peas in chili 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 vegetarian chili containing peas at 2 visits and rice 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.

02

Conditions studied

  • Post-prandial Glycaemic Response
  • Satiety

Keywords

  • blood sugar
  • insulin
  • appetite
  • peas
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Generally healthy male or female, between the age of 18-40 years;
  2. Body mass index (BMI) 18.5-30.0 kg/m2;
  3. Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively.
  4. Willing to provide informed consent;
  5. Willing/able to comply with the requirements of the study.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating;
  2. 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;
  3. Medical history of cardiovascular disease;
  4. Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
  5. Fasting plasma total cholesterol >7.8 mmol/L;
  6. Fasting plasma HDL \<0.9 mmol/L;
  7. Fasting plasma LDL >5.0 mmol/L;
  8. Fasting plasma triglycerides >2.3 mmol/L;
  9. Major surgery within the last 3 months;
  10. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
  11. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
  12. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
  13. 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;
  14. Active treatment for any type of cancer within 1 year prior to study start;
  15. 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);
  16. Smoking, use of tobacco or a nicotine replacement product (within the last 3 months);
  17. Allergies to peas;
  18. Aversion or unwillingness to eat study foods;
  19. Consuming >4 servings of pulses per week;
  20. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycaemia or appetite;
  21. Participation in another clinical trial, current or in the past 4 weeks;
  22. Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.
  23. Physical Activity Level >1.8.
  24. Restraint score >13 (factor 1) on the Three Factor Eating Questionnaire.
  25. 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;
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Whole yellow pea

    Chili containing 25g available carbohydrate from whole yellow peas. Intervention: Whole yellow pea chili

    Dietary Supplement: Whole yellow pea chili

  • Experimental
    Split yellow pea

    Chili containing 25g available carbohydrate from split yellow peas. Intervention: Split yellow pea chili

    Dietary Supplement: Split yellow pea chili

  • Placebo comparator
    Rice-PPGR

    Chili containing 25g available carbohydrate from long grain white rice. Intervention: Rice chili

    Dietary Supplement: Rice chili

  • Placebo comparator
    Rice-Satiety

    Rice chili with the same calories as the pea chili. Intervention: Rice chili

    Dietary Supplement: Rice chili

Interventions

  • Dietary supplementWhole yellow pea chili

    Chili containing whole yellow peas

  • Dietary supplementSplit yellow pea chili

    Chili containing split yellow peas

  • Dietary supplementRice chili

    Chili containing long grain white rice

05

What researchers measure

Primary outcomes

  1. Post-prandial glucose

    iAUC for glucose

    Time frame: 120 min

  2. Post-prandial insulin

    iAUC insulin

    Time frame: 120 min

Secondary outcomes

  1. Appetite scores

    AUC for hunger, fullness, desire to eat and prospective consumption using visual analog scales

    Time frame: 120 min

Other outcomes

  1. Calorie consumption

    number of calories consumed post-meal until bedtime

    Time frame: 16 h

  2. Metabolomics

    metabolite profile in plasma and urine

    Time frame: 120 min

  3. Acceptability of test products

    Ratings of color, aroma, flavor, texture and frequency of eating

    Time frame: 15 min

  4. Gastrointestinal effects

    Incidence and duration of gastrointestinal side effects

    Time frame: 24 h

06

Study locations

1 site
  • I.H. Asper Clinical Research Institute
    Winnipeg, Manitoba R2H2A6, Canada
07

References and documents

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 19526214 ↗
  • 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 2547300 ↗
  • 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 ↗
  • Smith 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 22916818 ↗
  • 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 ↗
  • European Food Safety Authority. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal. 2012;10(3):2604.
  • 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 ↗
  • Johansson 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 18392036 ↗
  • 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 ↗
  • Mollard RC, Luhovyy BL, Smith C, Anderson GH. Acute effects of pea protein and hull fibre alone and combined on blood glucose, appetite, and food intake in healthy young men--a randomized crossover trial. Appl Physiol Nutr Metab. 2014 Dec;39(12):1360-5. doi: 10.1139/apnm-2014-0170. Epub 2014 Aug 2. PubMed 25302637 ↗
  • Akhavan T, Anderson GH. Effects of glucose-to-fructose ratios in solutions on subjective satiety, food intake, and satiety hormones in young men. Am J Clin Nutr. 2007 Nov;86(5):1354-63. doi: 10.1093/ajcn/86.5.1354. PubMed 17991646 ↗

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT03306927
Lead sponsor
St. Boniface Hospital
Collaborators
Agriculture and Agri-Food Canada, University of Manitoba
Responsible party
Dr. Heather Blewett (Principal Investigator, St. Boniface Hospital) — Principal investigator
First posted
Oct 11, 2017
Start date
Nov 8, 2017
Primary completion
Nov 12, 2019
Completion
Jan 2025 (estimated)
Last update
Nov 29, 2024

Study contacts

Heather Blewett, PhD
principal investigator · Agriculture and Agri-Food Canada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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