The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients

Not Applicable

Completed

• Conditions: Blood Pressure; Uric Acid; Prehypertension
• Interventions: Other: Placebo; Dietary Supplement: Soursop supplementation

• Registration Number: NCT03531203
• Lead Sponsor: Gadjah Mada University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-10
• Primary Completion: 2018-01-12
• Study Completion: 2018-01-19
• Study First Submitted: 2018-04-26
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without Soursop	Placebo	Control group (without soursop group) was a group which do not receive any intervention (placebo)
With Soursop	Soursop supplementation	Treatment group (with soursop group) was a group which receive soursop supplementation

Primary Outcome Measures

Name	Time	Method
Change in baseline morning home blood pressure at week 7 and 13	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	Week 0, 7 and 13	Blood sample was taken to measure serum uric acid level

Secondary Outcome Measures

Name	Time	Method
Change in baseline CKD-Epi at week 7 and 13	Week 0, 7 and 13	Measurement of glomerular filtration rate
Change in baseline uric acid excretion at week 7 and 13	Week 0, 7 and 13	24-h urine sample was taken to measure uric acid excretion

Trial Locations

Locations (1)

Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi); 🇮🇩 Sleman, Yogyakarta, Indonesia