A Randomized, Controlled, Cross-over Trial Examining the Effect of Yellow Pea Flour in Bread on Post-prandial Glycaemic Response in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Post-prandial glucose
研究概览
简要总结
This study's overall goal is to investigate methods to improve the acceptability of pulse containing foods that provide a health benefit to consumers. The health benefits we are testing are post-prandial blood glucose attenuation and appetite related sensations in healthy human volunteers.
详细描述
A randomized, controlled, cross-over study designed to examine the post-prandial glycaemic response, metabolism of bioactives and appetite related sensations to 20% incorporation of yellow pea flour (untreated, heat treated with 0% moisture and heat treated with 10% moisture) into bread 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 bread containing 20% yellow pea flour at 3 visits and bread with 100% wheat flour at 1 visit. 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. Each visit will last approximately 3h 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 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN));
- •Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥3 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, and cannabis in any form (within the last 3 months);
- •Allergies to peas or wheat;
- •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 glucose
时间窗: 120 minutes
incremental area under the curve (iAUC) for glucose
Post-prandial insulin
时间窗: 120 minutes
iAUC insulin
次要结局
- Urinary metabolite profile(120 minutes)
- Plasma metabolite profile(120 minutes)
研究者
Dr. Heather Blewett
Principal Investigator
St. Boniface Hospital