A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas in Soup on Post-prandial Glycaemic Response in Healthy Adults.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Post-prandial insulin
研究概览
简要总结
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 in healthy human volunteers.
详细描述
A randomized, controlled, cross-over study designed to examine the post-prandial glycaemic response to peas in soup 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 3 clinic visits in a fasted state. Participants will be given soup containing peas at 2 visits and soup without peas at 1 visit. At each visit participants will provide 7 capillary blood samples via finger poke, 5 questionnaires about their appetite and a questionnaire about the acceptability of the products. Each visit will last approximately 2.5h and be separated by 3-14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •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 AST or ALT ≥1.5 times the upper limit of normal (ULN));
- •Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 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 (within the last 3 months);
- •Allergies to peas;
- •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;
结局指标
主要结局
Post-prandial insulin
时间窗: 120 min
iAUC for insulin
Post-prandial glucose
时间窗: 120 min
iAUC for glucose
次要结局
- Fullness(120 min)
- Desire to eat(120 min)
- Prospective consumption(120 min)
- Hunger(120 min)
研究者
Dr. Heather Blewett
Principal Investigator
St. Boniface Hospital