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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531203
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Mlati Study Group, Faculty of Medicine, Gadjah Mada University
Information provided by (Responsible Party):
Mochammad Sja'bani, Gadjah Mada University

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531203


Locations
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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
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Principal Investigator: Mochammad Sja'bani, PhD Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada
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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    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

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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:
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Prehypertension
Vascular Diseases
Cardiovascular Diseases