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

NCT ID: NCT03531203

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-10
• Study Completion Date: 2018-01-19

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.

Conditions

Blood Pressure; Prehypertension; Uric Acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

With Soursop

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

Group Type: EXPERIMENTAL

Soursop supplementation

Intervention Type: DIETARY_SUPPLEMENT

The soursop supplementation was given to treatment group (with soursop group) 2 times a day for 100 g each for 3 months period.

Without Soursop

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Control group (without soursop group) was left without treatment during study period

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Control group (without soursop group) was left without treatment during study period

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mlati Study Group, Faculty of Medicine, Gadjah Mada University

UNKNOWN

Sponsor Role: collaborator

Gadjah Mada University

OTHER

Sponsor Role: lead

Responsible Party

Mochammad Sja'bani

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mochammad Sja'bani, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada

Locations

Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)

Sleman, Special Region of Yogyakarta, Indonesia

Countries

Indonesia

Other Identifiers

Soursop Supplementation 2017

Identifier Type: -

Identifier Source: org_study_id