The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
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|ClinicalTrials.gov Identifier: NCT03531203|
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Prehypertension Uric Acid||Dietary Supplement: Soursop supplementation Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients|
|Actual Study Start Date :||July 10, 2017|
|Actual Primary Completion Date :||January 12, 2018|
|Actual Study Completion Date :||January 19, 2018|
Experimental: With Soursop
Treatment group (with soursop group) was a group which receive soursop supplementation
Dietary Supplement: Soursop supplementation
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)
Control group (without soursop group) was left without treatment during study period
- 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.
- 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
- Change in baseline CKD-Epi at week 7 and 13 [ Time Frame: Week 0, 7 and 13 ]Measurement of glomerular filtration rate
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531203
|Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)|
|Sleman, Yogyakarta, Indonesia, 55284|
|Principal Investigator:||Mochammad Sja'bani, PhD||Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada|