Effects of Black Soy Peptide Supplementation on Blood Pressure and Oxidative Stress:A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- change from baseline in Systolic blood pressure at 8 weeks
研究概览
简要总结
Black soy peptides have been shown to possess properties that may decrease blood pressure. To examine the effects of black soy peptides supplementation on blood pressure and oxidative stress in subjects with pre-hypertension or stage I hypertension.
详细描述
Trial participants included men and women aged 30 to 65 years who had an average systolic blood pressure (SBP) between 130 to 159 mmHg, average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an average of six measurements during two screening visits. Participants were supplied with 84 pouches of placebo (casein) or black soy peptide (3 pouches/day) at 0-week and at 4-week visits. Test group subjects received pouches containing black soy peptides (4.5 g/day total soy peptides for 8 weeks). The control group received pouches containing casein that had a similar appearance to the black soy peptide tablet. During the intervention, we instructed study participants to continue their current food intake patterns and lifestyles so that total energy intake and energy expenditure would be constant during the course of trial. Participants brought back unconsumed pouches at their 4- and 8-week follow-up visits. The dietitian counted the number of returned pouches, and we used this to assess the participants' adherence to their assigned intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Average systolic blood pressure (SBP) between 130 to 159 mmHg
- •Average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an average of six measurements during two screening visits
排除标准
- •Previous diagnosed clinical hypertension
- •Self-reported use of anti-hypertensive medication
- •Abnormal liver or renal function
- •History of cardiovascular disease, cancer, thyroid or pituitary disease, or any other serious life-threatening illness that required regular medical treatment
结局指标
主要结局
change from baseline in Systolic blood pressure at 8 weeks
时间窗: 8 weeks
次要结局
- Change from baseline in Diastolic blood pressure at 8 weeks(8 weeks)
- change from baseline in Urinary 8-epi-prostaglandin F2 at 8 weeks(8 weeks)
- change from baseline in Renin at 8 weeks(8 weeks)
- Change from baseline in angiotensin-converting enzyme at 8 weeks(8 weeks)
- change from baseline in plasma malondialdehyde at 8 weeks(8 weeks)