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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531203
• Other study ID #: Soursop Supplementation 2017
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: January 19, 2018

Study information

• Verified date: May 2018
• Source: Gadjah Mada University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: January 19, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Prehypertension
• Uric Acid

Intervention

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.

Other:
• Placebo
Control group (without soursop group) was left without treatment during study period

Locations

Country	Name	City	State
Indonesia	Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)	Sleman	Yogyakarta

Sponsors (2)

Lead Sponsor	Collaborator
Gadjah Mada University	Mlati Study Group, Faculty of Medicine, Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline morning home blood pressure at week 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.	Week 0, 7 and 13
Primary	Change in baseline serum uric acid at week 7 and 13	Blood sample was taken to measure serum uric acid level	Week 0, 7 and 13
Secondary	Change in baseline CKD-Epi at week 7 and 13	Measurement of glomerular filtration rate	Week 0, 7 and 13
Secondary	Change in baseline uric acid excretion at week 7 and 13	24-h urine sample was taken to measure uric acid excretion	Week 0, 7 and 13