Effect of Peas in Muffins on Blood Glucose and Appetite Control

Satiety Clinical Trial

— PEA3  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03306706
• Other study ID #: RRC/2017/1702
• Secondary ID: HS21108 (B2017:1
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: St. Boniface Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: January 2025
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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:

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;

Related Conditions & MeSH terms

• Post-prandial Glycaemic Response
• Satiety

Intervention

Dietary Supplement:
• Whole pea muffins
2 muffins containing whole peas
• Split pea muffins
2 muffins containing split peas
• Wheat muffins
2 muffins containing wheat

Locations

Country	Name	City	State
Canada	I.H. Asper Clinical Research Institute	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
St. Boniface Hospital	Agriculture and Agri-Food Canada, University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	calorie intake	Number of calories consumed post-intervention until bedtime	16 hours
Other	Metabolomics	Metabolite profile in plasma and urine	120 min
Other	Acceptability of test products	Rating of color, aroma, flavor, texture and frequency of eating	15 min
Other	Gastrointestinal side effects	Incidence and duration of GI side effects	24h
Primary	Post-prandial glucose response	iAUC glucose	120 min
Primary	Post-prandial insulin	iAUC insulin	120 min
Secondary	Appetite ratings	AUC for hunger, fullness, desire to eat and prospective consumption using visual analog scales	120 min