The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Change in baseline morning home blood pressure at week 7 and 13
研究概览
简要总结
This study was a randomized controlled trial study. The aim of this study was to determine the effect of soursop fruit supplementation on blood pressure (BP), serum uric acid (SUA), and kidney function.
The definition of prehypertension and hypertension was accepted as delivered in The Seventh Report of the Joint National Committee (JNC 7) as the systolic BP was 120 - 139 mmHg and diastolic BP was 80 - 89 mmHg for prehypertension, while systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg for hypertension.
Based on the study by Sja'bani (2014), the cut-off point of (SUA) was divided into 3 categories, which are normal (< 5 mg/dL), high-normal (5 - <7 mg/dL), and high (≥ 7 mg/dL).
A number of 143 people with essential prehypertension and high normal uric acid level were assigned as subject in this study. Subjects were randomly assigned into two groups which are treatment and control group. For a 3 months period, the treatment group was given 2x100 g soursop fruit juice per day and the control group was left without treatment.
Blood pressure was measured by medical team using Omron HEM-907 (digital automatic blood pressure monitoring) every 2 weeks (3 times readings for each) in each subject's home. Subjects were examined in sitting position. Evaluation of laboratory examination was taken at week 0, 7 and 13.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pre-hypertensive patients in accordance with JNC 7 (Joint National Committee 7) criteria,
- •male or female resident in Mlati, Sleman with or without family history of hypertension,
- •age 30-59 years,
- •high normal uric acid levels (≥ 5 and < 7 mg/dL) and
- •agreed to follow the study by giving their informed consent.
排除标准
- •have a history of diabetes, chronic renal failure,
- •using hormonal contraceptive,
- •in pregnancy,
- •taking uric acid-lowering drugs (allopurinol, probenecid),
- •positive urine reduction, positive proteinuria, creatinine > 1.5 g/dL, Blood Glucose > 126 g/dL.
研究组 & 干预措施
With Soursop
Treatment group (with soursop group) was a group which receive soursop supplementation
干预措施: Soursop supplementation (Dietary Supplement)
Without Soursop
Control group (without soursop group) was a group which do not receive any intervention (placebo)
干预措施: Placebo (Other)
结局指标
主要结局
Change in baseline morning home blood pressure at week 7 and 13
时间窗: Week 0, 7 and 13
Blood pressure was measured by medical team using Omron HEM-907 (digital automatic blood pressure monitoring) every 2 weeks (3 times readings for each) in each subject's home. Subjects were examined in sitting position.
Change in baseline serum uric acid at week 7 and 13
时间窗: Week 0, 7 and 13
Blood sample was taken to measure serum uric acid level
次要结局
- Change in baseline uric acid excretion at week 7 and 13(Week 0, 7 and 13)
- Change in baseline CKD-Epi at week 7 and 13(Week 0, 7 and 13)
研究者
Mochammad Sja'bani
Professor
Gadjah Mada University