Assessing the Blood Glucose Response of Novel Wild Rice Enhanced Food Products (ABWE) Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Dylan MacKay
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The effects of different wild rice products compared to products currently on the market on glycaemic control.
研究概览
简要总结
The goal of this acute double-blind cross over trial to test the effects of different wild rice cereal products compared to products currently on the market on glycaemic control. The main questions it aims to answer are:
- What is the effect compared to products currently on the market on glycaemic control?
- Is the wild rice product palatable?
Participants will:
- consent to attend 6 study visits being 2.5 hours each
- come to each visit fasted for at least 10-12 hours.
- complete a Motivation to Eat VAS following each blood measure
详细描述
The study will consist of 2 acute double-blind cross-over trials and both trials investigate types of wild rice products tested against a white rice or white bread control. This is the second of the two trials and will be assessing four wild rice cereals against two control rice cereals.
Participants will fast and arrive at the RCFTR between 8 and 10:30 am on the session day. They will be provided either of the study treatment based on randomization sequence. Baseline blood glucose (0 min) will be measured twice via finger stick blood sample right before their first bite of the study product, and at 15, 30, 45, 60, 90 and 120 mins after baseline in duplicate. The timer will be started when they take their first bite. VAS will be completed following consumption of the treatments to measure palatability.
The primary objective is to test the effects of different wild rice products compared to products currently on the market by evaluating factors that influence glycemic response to wild rice in humans, performed via the finger stick blood glucose that will be measured throughout each session as outlined above.
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
- Double (Participant, Investigator)
盲法说明
The allocation of this intervention order will be blinded for the investigators and the participants. Treatment will be given blinded names, such as A and B, but it may be possible to determine what each treatment is due to its appearance, however we will not be informing the participants what the treatments are. The study staff who will be preparing and overseeing the treatments may not be blinded due to the different appearances of the treatments. However, the staff that will conduct the trial results analyses will not be un-blinded until the analyses are complete.
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/m2
- •Fasting glucose <5.6 mmol/L
- •Usually eat breakfast
- •Participant must receive at least two doses of COVID-19 vaccine that have been recognized by Winnipeg Regional Health Authorities.
- •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 study treatments within 10 minutes
- •Use of medication or supplements that may influence carbohydrate metabolism, including, not limit 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 rice
- •Existing restrictive dietary habits (such a vegan, low carbohydrate/keto) Date and version No: December 12 , 2022, Version 2 Page 7 of 15
- •History of hypertension
- •History of cancer within the last two years (except for non-melanoma skin cancer)
- •Recent history (within 12 month of screening) or current consumption of >14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
- •Body weight change over 3.5kg for 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 months
结局指标
主要结局
The effects of different wild rice products compared to products currently on the market on glycaemic control.
时间窗: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 mins after the first bite of treatment.
Finger stick blood glucose will be measured throughout each session.
次要结局
- To measure the palatability of the wild rice products following consumption.(VAS measuring palatability will be completed right after the consumption of the treatments.)
研究者
Dylan MacKay
Assistant Professor
University of Manitoba