The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Yogyakarta
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Sleman, Yogyakarta, Indonesia, 55284
- Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: With Soursop
Treatment group (with soursop group) was a group which receive soursop supplementation
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The soursop supplementation was given to treatment group (with soursop group) 2 times a day for 100 g each for 3 months period.
|
|
Placebo Comparator: Without Soursop
Control group (without soursop group) was a group which do not receive any intervention (placebo)
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Control group (without soursop group) was left without treatment during study period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in baseline morning home blood pressure at week 7 and 13
Time Frame: 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.
|
Week 0, 7 and 13
|
|
Change in baseline serum uric acid at week 7 and 13
Time Frame: Week 0, 7 and 13
|
Blood sample was taken to measure serum uric acid level
|
Week 0, 7 and 13
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in baseline CKD-Epi at week 7 and 13
Time Frame: Week 0, 7 and 13
|
Measurement of glomerular filtration rate
|
Week 0, 7 and 13
|
|
Change in baseline uric acid excretion at week 7 and 13
Time Frame: Week 0, 7 and 13
|
24-h urine sample was taken to measure uric acid excretion
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Week 0, 7 and 13
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mochammad Sja'bani, PhD, Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soursop Supplementation 2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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