Effects of Peas on Blood Glucose Control
关键词
抽象
描述
A randomized, controlled, cross-over study designed to examine the PPGR to peas will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. The study will be divided into 2 groups of 24 healthy volunteers each. In Group 1, eligible participants who have provided consent will be asked to attend 6 clinic visits in a fasted state. Participants will be given white bread at their first and last visits, peas with rice at 3 visits and rice at 1 visit. At each visit participants will provide 7 blood samples via finger poke, 6 questionnaires about their appetite and a questionnaire about the acceptability of the test food. Each visit will last approximately 2.5h and be separated by 3-10 days. Group 2 will undergo the exact same study procedures as group 1, but rice will be replaced with potato.
日期
最后验证: | 08/31/2019 |
首次提交: | 07/26/2015 |
提交的预估入学人数: | 09/15/2015 |
首次发布: | 09/16/2015 |
上次提交的更新: | 09/23/2019 |
最近更新发布: | 09/24/2019 |
实际学习开始日期: | 10/15/2015 |
预计主要完成日期: | 08/13/2017 |
预计完成日期: | 02/29/2020 |
状况或疾病
干预/治疗
Other: Group1
Other: Group2
相
手臂组
臂 | 干预/治疗 |
---|---|
Placebo Comparator: White bread 1 Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant | |
Experimental: Pea variety 1 with rice Group 1,Visit 2-5 Pea variety 1 with rice (25g available carbohydrate of each) given as breakfast to fasting participants | |
Experimental: Pea variety 2 with rice Group 1, Visit 2-5 Pea variety 2 with rice (25g available carbohydrate of each) given as breakfast to fasting participants | |
Experimental: Pea variety 3 with rice Group 1, Visit 2-5 Pea variety 3 with rice (25g available carbohydrate of each) given as breakfast to fasting participants | |
Experimental: Rice Group 1, Visit 2-5 Rice (equal to 50g available carbohydrate) given as breakfast to fasting participants | |
Placebo Comparator: White bread 2 Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant | |
Experimental: Pea variety 1 with potato Group 2, Visit 2-5 Pea variety 1 with potato (25g available carbohydrate of each) given as breakfast to fasting participants | |
Experimental: Pea variety 2 with potato Group 2, Visit 2-5 Pea variety 2 with potato (25g available carbohydrate of each) given as breakfast to fasting participants | |
Experimental: Pea variety 3 with potato Group 2, Visit 2-5 Pea variety 3 with potato (25g available carbohydrate of each) given as breakfast to fasting participants | |
Experimental: Potato Group2, Visit 2-5 Potato (equal to 50g available carbohydrate) given as breakfast to fasting participants |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion criteria 1. Generally healthy male or female, between the age of 18-40 years; 2. Body mass index (BMI) 18.5-34.5 kg/m2; 3. HbA1c <6.0%; 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 plasma glucose ≥7.0 mmol/L 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. A change in blood glucose concentration less than 1 mmol/L between baseline and 30 minutes after consumption of white bread at visit 1; 10. Maximum blood glucose concentration occurs after 60 minutes after consumption of white bread at visit 1; 11. Major surgery within the last 3 months; 12. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months; 13. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN)); 14. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN)); 15. 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 with the past 6 weeks; 16. Active treatment for any type of cancer within 1 year prior to study start; 17. 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; 18. Shift worker; 19. Tobacco use current or within the last 3 months; 20. Allergies to peas; 21. Aversion or unwillingness to eat study foods; 22. Consuming >4 servings of pulses per week; 23. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycemia; 24. Participation in another clinical trial, current or in the past 4 weeks; 25. Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program. |
结果
主要结果指标
1. Postprandial blood glucose [up to 2 hours following a meal]
2. Postprandial blood insulin [up to 2 hours following a meal]
次要成果指标
1. Hunger (Visual analogue scales) [up to 2 hours following a meal]
2. Fullness (Visual analogue scales) [up to 2 hours following a meal]
3. Desire to eat (Visual analogue scales) [up to 2 hours following a meal]
其他成果措施
1. Acceptability of test products based on sensory scales [immediately after eating test product]
2. Gastrointestinal side effects [up to 24 hours following a meal]