A Randomized Controlled Pilot Study Evaluating the Effect of Oat Polyphenols on Post-prandial Glucose Response in Healthy Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- post-prandial glucose response
研究概览
简要总结
The trial will use a two period acute double-blind cross-over design to compare the effects of a serving of oatmeal containing high or low amounts of avenanthramides (AV) on post-prandial blood glucose response in healthy adults.
详细描述
The clinical trial will follow a two period acute double-blind cross-over design. It will take place at Richardson Centre for Functional Food and Nutraceuticals (RCFFN) at University of Manitoba, Winnipeg, Canada.
The trial will recruit healthy adult participants. Participants will consent to participate in two acute feeding sessions. Participants will be randomized to either control (low avenanthramides) then treatment (high avenanthramides) or treatment then control. Participants will arrive at the study center fasted between 8 and 10:30 am on the session days. They will be provided either the study treatment or control product based on randomization sequence for their first study visit. Baseline blood glucose (0 min) will be measured in duplicate via finger stick blood sample right before their first bite of the treatment product, and at 15, 30, 45, 60, 90 and 120 mins after baseline. The timer will be started when they take their first bite. During the second visit participant will consume the other treatment based on the randomization (the oatmeal that they didn't receive in their first visit and follow exactly the same procedure as the first visit). There will be a minimum of 5 days between sessions. Female participants will be scheduled during the luteal phase of their menstruation cycle. There will be a maximum of 8 weeks between the two sessions, therefore, participants will finish the both sessions within an 8 week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the trial
- •Male or female between 18-50 years old
- •BMI range in between 18.9-29.9 kg/m^2
- •Fasting glucose <5.6 mmol/L
- •Usually eat breakfast
- •In the Investigator's opinion is able and willing to comply with all trial requirements
排除标准
- •Fasting glucose ≥ 5.6 mmol/L or <3.5 mmol/L
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- •Participants who indicate that they could not finish consuming the study treatments within 10 minutes
- •Use of medication or supplements that may influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of screening visit
- •History of disordered eating, AIDS, hepatitis, a history of clinically important endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including but not limit to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders
- •Intolerance or allergic reaction to oats
- •Existing restrictive dietary habits (such a vegan, low carbohydrate or keto)
- •Uncontrolled hypertension
- •History of cancer within the last two years (except for non-melanoma skin cancer)
- •Recent history of (within 12 month of screening) or current strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
- •Body weight change over 3.5kg within the past 3 months
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks
- •Had significant physical trauma or major surgery in the past 3 month or had trauma or major surgery in the past 3 month
结局指标
主要结局
post-prandial glucose response
时间窗: Area under the curve from 0,15, 30, 45, 60, 90 and 120 minutes
2 hour area under the curve of post-prandial glucose response to the interventions in mmol/L\*min\^2
次要结局
未报告次要终点
研究者
Dylan MacKay. PhD
Assistant Professor
University of Manitoba