The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
Primary Purpose
Blood Pressure, Prehypertension, Uric Acid
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Soursop supplementation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Blood Pressure focused on measuring soursop, supplementation, prehypertension, uric acid, randomized controlled trial
Eligibility Criteria
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.
Sites / Locations
- Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
With Soursop
Without Soursop
Arm Description
Treatment group (with soursop group) was a group which receive soursop supplementation
Control group (without soursop group) was a group which do not receive any intervention (placebo)
Outcomes
Primary Outcome Measures
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.
Change in baseline serum uric acid at week 7 and 13
Blood sample was taken to measure serum uric acid level
Secondary Outcome Measures
Change in baseline CKD-Epi at week 7 and 13
Measurement of glomerular filtration rate
Change in baseline uric acid excretion at week 7 and 13
24-h urine sample was taken to measure uric acid excretion
Full Information
NCT ID
NCT03531203
First Posted
April 26, 2018
Last Updated
May 8, 2018
Sponsor
Gadjah Mada University
Collaborators
Mlati Study Group, Faculty of Medicine, Gadjah Mada University
1. Study Identification
Unique Protocol Identification Number
NCT03531203
Brief Title
The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
Official Title
The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
January 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadjah Mada University
Collaborators
Mlati Study Group, Faculty of Medicine, Gadjah Mada University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Prehypertension, Uric Acid
Keywords
soursop, supplementation, prehypertension, uric acid, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With Soursop
Arm Type
Experimental
Arm Description
Treatment group (with soursop group) was a group which receive soursop supplementation
Arm Title
Without Soursop
Arm Type
Placebo Comparator
Arm Description
Control group (without soursop group) was a group which do not receive any intervention (placebo)
Intervention Type
Dietary Supplement
Intervention Name(s)
Soursop supplementation
Intervention Description
The soursop supplementation was given to treatment group (with soursop group) 2 times a day for 100 g each for 3 months period.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Control group (without soursop group) was left without treatment during study period
Primary Outcome Measure Information:
Title
Change in baseline morning home blood pressure at week 7 and 13
Description
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
Title
Change in baseline serum uric acid at week 7 and 13
Description
Blood sample was taken to measure serum uric acid level
Time Frame
Week 0, 7 and 13
Secondary Outcome Measure Information:
Title
Change in baseline CKD-Epi at week 7 and 13
Description
Measurement of glomerular filtration rate
Time Frame
Week 0, 7 and 13
Title
Change in baseline uric acid excretion at week 7 and 13
Description
24-h urine sample was taken to measure uric acid excretion
Time Frame
Week 0, 7 and 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mochammad Sja'bani, PhD
Organizational Affiliation
Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)
City
Sleman
State/Province
Yogyakarta
ZIP/Postal Code
55284
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
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