Effect of Peas in Chili on Blood Glucose and Appetite Control

NCT ID: NCT03306927

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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Post-prandial Glycaemic Response Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, controlled, cross-over study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Whole yellow pea

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

Group Type EXPERIMENTAL

Whole yellow pea chili

Intervention Type DIETARY_SUPPLEMENT

Chili containing whole yellow peas

Split yellow pea

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

Group Type EXPERIMENTAL

Split yellow pea chili

Intervention Type DIETARY_SUPPLEMENT

Chili containing split yellow peas

Rice-PPGR

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

Group Type PLACEBO_COMPARATOR

Rice chili

Intervention Type DIETARY_SUPPLEMENT

Chili containing long grain white rice

Rice-Satiety

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

Group Type PLACEBO_COMPARATOR

Rice chili

Intervention Type DIETARY_SUPPLEMENT

Chili containing long grain white rice

Interventions

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Whole yellow pea chili

Chili containing whole yellow peas

Intervention Type DIETARY_SUPPLEMENT

Split yellow pea chili

Chili containing split yellow peas

Intervention Type DIETARY_SUPPLEMENT

Rice chili

Chili containing long grain white rice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role collaborator

St. Boniface Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Heather Blewett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heather Blewett, PhD

Role: PRINCIPAL_INVESTIGATOR

Agriculture and Agri-Food Canada

Locations

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I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND

Public Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19526214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2547300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22145774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22916818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6293296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19443236 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21425674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20122136 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 25850814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18392036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20920440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25302637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17991646 (View on PubMed)

Other Identifiers

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HS21116 (B2017:108)

Identifier Type: OTHER

Identifier Source: secondary_id

RRC/2017/1703

Identifier Type: -

Identifier Source: org_study_id