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

Gadjah Mada University

Status: Completed

Conditions: Prehypertension; Uric Acid; Blood Pressure

Treatments: Other: Placebo; Dietary Supplement: Soursop supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03531203

Soursop Supplementation 2017

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 30 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups, including a placebo group

With Soursop

Experimental group

Description:

Treatment group (with soursop group) was a group which receive soursop supplementation

Treatment:

Dietary Supplement: Soursop supplementation

Without Soursop

Placebo Comparator group

Description:

Control group (without soursop group) was a group which do not receive any intervention (placebo)

Treatment:

Other: Placebo