Blood Pressure Clinical Trial
Official title:
The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
Verified date | May 2018 |
Source | Gadjah Mada University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 143 |
Est. completion date | January 19, 2018 |
Est. primary completion date | January 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 59 Years |
Eligibility |
Inclusion Criteria: 1. pre-hypertensive patients in accordance with JNC 7 (Joint National Committee 7) criteria, 2. male or female resident in Mlati, Sleman with or without family history of hypertension, 3. age 30-59 years, 4. high normal uric acid levels (= 5 and < 7 mg/dL) and 5. agreed to follow the study by giving their informed consent. Exclusion Criteria: 1. have a history of diabetes, chronic renal failure, 2. using hormonal contraceptive, 3. in pregnancy, 4. taking uric acid-lowering drugs (allopurinol, probenecid), 5. positive urine reduction, positive proteinuria, creatinine > 1.5 g/dL, Blood Glucose > 126 g/dL. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi) | Sleman | Yogyakarta |
Lead Sponsor | Collaborator |
---|---|
Gadjah Mada University | Mlati Study Group, Faculty of Medicine, Gadjah Mada University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in baseline morning home blood pressure at week 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. | Week 0, 7 and 13 | |
Primary | Change in baseline serum uric acid at week 7 and 13 | Blood sample was taken to measure serum uric acid level | Week 0, 7 and 13 | |
Secondary | Change in baseline CKD-Epi at week 7 and 13 | Measurement of glomerular filtration rate | Week 0, 7 and 13 | |
Secondary | Change in baseline uric acid excretion at week 7 and 13 | 24-h urine sample was taken to measure uric acid excretion | Week 0, 7 and 13 |
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