Effect of Oat Beta Glucan in Managing Blood Pressure: a Randomized Cross-over Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Mean systolic blood pressure
研究概览
简要总结
This is a randomized, double-blinded, cross-over pilot study comparing the effects of ingesting oats containing high molecular weight β-glucan in reducing blood pressure.
详细描述
The pilot study will consist of 2 study periods: one treatment period and one control period. The treatment period will provide food products made from oats containing a total of 4 grams per day high molecular weight (HMW) oat β-glucan, whereas, the control period will provide food products made primarily from wheat with no β-glucan. The study will be located at the Chronic Disease Innovation Centre in Seven Oaks General Hospital, Winnipeg, Canada.
The primary objective of this study is to investigate the effect of ingestion of HMW oat β-glucan on ambulatory blood pressure. Participants will be asked to wear an ambulatory blood pressure monitor for 24 hours per day for 3 consecutive days at the beginning and end of each treatment period. This device automatically measures blood pressure every 15-30 minutes during the day and 30 to 60 minutes during the evening.
The study has been designed to be conducted virtually. Participants will consent to receive both treatment and control over two 4-week periods online. The participants will be randomized to different orders of treatment, with a 4 week wash out period in between.
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)
盲法说明
Treatments will be provided to participants' homes via delivery. The treatments will be in similar looking breakfast cookies that will be prepared and delivered people outside of the clinical trial team.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the trial
- •Generally healthy male and non-pregnant/lactating female, between the ages of 40-75
- •When measured by the ambulatory blood pressure monitor, average systolic blood pressure (between 120 and 150mm Hg) and diastolic blood pressure (between 75 and 100mm Hg)
- •Willing to comply with protocol requirements
- •Willing to maintain their current weight and activity level throughout the study
- •Body mass index 18.5-35kg/m2
排除标准
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- •Body mass index ≤ 18.4 and ≥ 35.1 kg/m2
- •If there is a history of a secondary cause of hypertension
- •Ambulatory blood pressure monitor, systolic blood pressure >150mm Hg or <120mm Hg, diastolic pressure >100mm Hg or <75 mm Hg
- •Use of medications containing pseudoephedrine or other vasoconstricting agents
- •Antihypertensive drug treatment, regular high dose nonsteroidal anti-inflammatory drugs (NSAID) treatment and the use of cyclosporine or tacrolimus
- •Cardiovascular disease including stroke, congestive heart failure, myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack within six months prior to screening
- •Not willing to maintain their regular physical activity level throughout the intervention
- •Use of omega-3 fatty acid, herbal supplements or weight loss drugs
- •Diagnosis of diabetes type 1 or type 2
- •Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
- •Any other significant disease or disorder which, in the opinion of the Investigator or study physician, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- •Recent history (within 6 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
- •Smokers and tobacco/snuff/nicotine users
- •Allergy to oats, wheat, peanut, apple, cherry, blueberry, quinoa, egg white, margarine and vanilla extract.
- •Regular consumption of supplements which may influence blood pressure/consumption of food supplements targeted to blood pressure lowering within 30 days before and during the study
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks
结局指标
主要结局
Mean systolic blood pressure
时间窗: Day 1 to 3 and day 26-28 of each study period
The mean systolic blood pressure will be measured for 24 hours for 3 consecutive days with an ambulatory blood pressure machine
次要结局
- Waist circumference(Day 1 and day 28 of each study period)
- Mean diastolic blood pressure(Day 1, 2, and 3 and day 26, 27, and 28 of each study period)
- Mean arterial blood pressure(Day 1, 2, and 3 and day 26, 27, and 28 of each study period)
- Body weight(Day 1 and day 28 of each study period)