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NCT Number: NCT03531203

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

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.

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Key information

Conditions

Blood Pressure Cardiovascular Diseases Prehypertension Uric Acid Vascular Diseases

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Sleman, Special Region of Yogyakarta, 55284, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pre-hypertensive patients in accordance with JNC 7 (Joint National Committee 7) criteria,
  • male or female resident in Mlati, Sleman with or without family history of hypertension,
  • age 30-59 years,
  • high normal uric acid levels (≥ 5 and < 7 mg/dL) and
  • agreed to follow the study by giving their informed consent.

Exclusion criteria

  • have a history of diabetes, chronic renal failure,
  • using hormonal contraceptive,
  • in pregnancy,
  • taking uric acid-lowering drugs (allopurinol, probenecid),
  • positive urine reduction, positive proteinuria, creatinine > 1.5 g/dL, Blood Glucose > 126 g/dL.

Treatment and study plan

Soursop supplementation

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.

Placebo

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Collaborators

  • Mlati Study Group, Faculty of Medicine, Gadjah Mada University

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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