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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03531203
Other study ID # Soursop Supplementation 2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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