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

• ClinicalTrials.gov Identifier: NCT03531203
• Recruitment Status: Completed
• First Posted: May 21, 2018
• Last Update Posted: May 21, 2018
• Sponsor: Gadjah Mada University
• Collaborator: Mlati Study Group, Faculty of Medicine, Gadjah Mada University
• Information provided by (Responsible Party): Mochammad Sja'bani, Gadjah Mada University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Blood Pressure; Prehypertension; Uric Acid	Dietary Supplement: Soursop supplementation; Other: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 143 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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)	Other: Placebo; Control group (without soursop group) was left without treatment during study period

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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

Secondary Outcome Measures :

1. Change in baseline CKD-Epi at week 7 and 13 [ Time Frame: Week 0, 7 and 13 ]
   Measurement of glomerular filtration rate
2. 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

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Indonesia

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

Sleman, Yogyakarta, Indonesia, 55284

Sponsors and Collaborators

Gadjah Mada University

Mlati Study Group, Faculty of Medicine, Gadjah Mada University

Investigators

• Principal Investigator: Mochammad Sja'bani, PhD; Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada

More Information

• Responsible Party: Mochammad Sja'bani, Professor, Gadjah Mada University
• ClinicalTrials.gov Identifier: NCT03531203
• Other Study ID Numbers: Soursop Supplementation 2017
• First Posted: May 21, 2018
• Last Update Posted: May 21, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mochammad Sja'bani, Gadjah Mada University:

soursop; supplementation; prehypertension; uric acid; randomized controlled trial

Additional relevant MeSH terms:

Prehypertension; Vascular Diseases; Cardiovascular Diseases