Clinical trial NCT03531203: The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
Official title: The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Prehypertension
Uric Acid
Keywords: soursop
supplementation
prehypertension
uric acid
randomized controlled trial
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
Collaborators: name: Mlati Study Group, Faculty of Medicine, Gadjah Mada University
First posted: 2018-05-21
Enrollment: 143
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in baseline morning home blood pressure at week 7 and 13
timeFrame: Week 0, 7 and 13
measure: Change in baseline serum uric acid at week 7 and 13
timeFrame: Week 0, 7 and 13
Secondary outcomes:
measure: Change in baseline CKD-Epi at week 7 and 13
timeFrame: Week 0, 7 and 13
measure: Change in baseline uric acid excretion at week 7 and 13
timeFrame: Week 0, 7 and 13
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)
state: Yogyakarta
Study officials:
affiliation: Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada
name: Mochammad Sja'bani, PhD
role: PRINCIPAL_INVESTIGATOR
References: