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CompletedNCT03531203Updated May 21, 2018

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

An interventional study of Soursop supplementation and Placebo in Blood Pressure, Prehypertension and Uric Acid, sponsored by Gadjah Mada University. Completed at 1 site in Indonesia. Open to participants aged 30 Years to 59 Years. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by Gadjah Mada University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
30 Years to 59 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Blood Pressure
  • Prehypertension
  • Uric Acid

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Keywords

  • soursop
  • supplementation
  • prehypertension
  • uric acid
  • randomized controlled trial
03

In context

Prehypertension

145 studies on the registry are indexed under Prehypertension; 21 are open to participants now.

This study's enrollment of 143 is above the median of 62 across 127 interventional studies indexed under Prehypertension.

Browse Prehypertension studies →

Lead sponsor

Gadjah Mada University is the lead sponsor of 62 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
143 participants (actual)

Study arms

  • Experimental
    With Soursop

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

    Dietary Supplement: Soursop supplementation

  • Placebo comparator
    Without Soursop

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

    Other: Placebo

Interventions

  • Dietary supplementSoursop supplementation

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

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 0, 7 and 13

  2. Change in baseline serum uric acid at week 7 and 13

    Blood sample was taken to measure serum uric acid level

    Time frame: Week 0, 7 and 13

Secondary outcomes

  1. Change in baseline CKD-Epi at week 7 and 13

    Measurement of glomerular filtration rate

    Time frame: Week 0, 7 and 13

  2. Change in baseline uric acid excretion at week 7 and 13

    24-h urine sample was taken to measure uric acid excretion

    Time frame: Week 0, 7 and 13

07

Study locations

1 site
  • Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)
    Sleman, Yogyakarta 55284, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03531203
Lead sponsor
Gadjah Mada University
Collaborators
Mlati Study Group, Faculty of Medicine, Gadjah Mada University
Responsible party
Mochammad Sja'bani (Professor, Gadjah Mada University) — Principal investigator
First posted
May 21, 2018
Start date
Jul 10, 2017
Primary completion
Jan 12, 2018
Completion
Jan 19, 2018
Last update
May 21, 2018

Study contacts

Mochammad Sja'bani, PhD
principal investigator · Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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