Clinical Trial of Protein and Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 352
- 主要终点
- Change From Baseline in Average Systolic Blood Pressure at 8 Weeks
研究概览
简要总结
The purpose of this randomized, double-blind, controlled trial is to examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension.
详细描述
Background: Epidemiologic studies suggest that vegetable protein intake is inversely related to blood pressure.
Objectives: To examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension
Design: Randomized, double-blind, controlled trial
Study Participants: 350 participants, aged 35-64 years, with an initial untreated systolic blood pressure of 130-159 mmHg and/or diastolic blood pressure of 80-99 mmHg
Intervention: Study participants will be randomly assigned to take 40-grams of isolated soybean protein supplements per day or complex carbohydrate control for 12 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomization assignment list was generated by a computer program that could only be accessed by the study data coordinator. Apart from the data coordinator, all research personnel, including investigators, study coordinators, and BP technicians, and the study participants were unaware of treatment assignment.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systolic BP of 120 to 159 mm Hg and diastolic BP of 80 to 95 mm Hg (average of 6 measurements at 2 screening visits)
- •Willing to participate in all aspects of the study
排除标准
- •Consumption of dietary protein greater than or equal to 1.63 grams/kg per day, as determined by two 24-hour dietary recalls
- •Stage-2 or higher severe hypertension (systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 95 mm Hg)
- •Use of antihypertensive medications or medications that affect BP
- •History of clinical heart disease (e.g., angina/heart attack, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
- •Kidney disease (serum creatinine level greater than or equal to 1.7 mg/dL for men and greater than or equal to 1.5 mg/dL for women)
- •Current hypercholesterolemia (fasting serum total cholesterol greater than or equal to 240 mg/dL) or use of cholesterol-lowering medications
- •Current diabetes (fasting serum glucose greater than or equal to 126 mg/dL) or use of insulin or oral hypoglycemic agents
- •Severe obesity (body mass index greater than or equal to 40 kg/m²)
- •Current use of prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss greater than 15 pounds within the 6 months prior to study entry
- •Cancer (except non-melanoma skin cancer) that required treatment during the year prior to study entry
- •Consumption of more than 14 alcoholic beverages per week
- •Current participation in another medical study
- •Consumption of milk or soy protein greater than or equal to the 90th percentile of intake in the U.S. general population
- •Has another member of the household participating in the study
- •Study employees or living with study employees
- •Allergy or intolerance to soy protein or milk protein products
- •Allergy to aspartame
- •Plans to move out of the study area (greater than or equal to 50 miles from the study site) and has difficulty coming to the study site
- •Inability or unwillingness to cooperate during the screening visits
- •Poor compliance during the screening period (intake of less than 85% of supplements)
- •Pregnant or plans to become pregnant during the study
结局指标
主要结局
Change From Baseline in Average Systolic Blood Pressure at 8 Weeks
时间窗: Baseline and 8 Weeks
The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from 2 baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements.
次要结局
- Change From Baseline in Serum LDL-cholesterol at 8 Weeks(Baseline and 8 Weeks)
- Body Weight at 8 Weeks(Baseline and 8 Weeks)