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| Name | Class |
|---|---|
| Mlati Study Group, Faculty of Medicine, Gadjah Mada University | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Soursop | Experimental | Treatment group (with soursop group) was a group which receive soursop supplementation |
|
| Without Soursop | Placebo Comparator | Control group (without soursop group) was a group which do not receive any intervention (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline CKD-Epi at week 7 and 13 | Measurement of glomerular filtration rate | Week 0, 7 and 13 |
| Change in baseline uric acid excretion at week 7 and 13 | 24-h urine sample was taken to measure uric acid excretion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mochammad Sja'bani, PhD | Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi) | Sleman | Special Region of Yogyakarta | 55284 | Indonesia |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Other | Control group (without soursop group) was left without treatment during study period |
|
| Week 0, 7 and 13 |