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

NCT03531203 | Completed

• 1 other identifier: Soursop Supplementation 2017
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Prehypertension; Uric Acid

Keywords

soursop; supplementation; prehypertension; uric acid; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Change in baseline CKD-Epi at week 7 and 13

  Week 0, 7 and 13

• Change in baseline uric acid excretion at week 7 and 13

  Week 0, 7 and 13

Study Arms (2)

With Soursop

EXPERIMENTAL

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

Dietary Supplement: Soursop supplementation

Without Soursop

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

With Soursop

Placebo OTHER

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

Without Soursop

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gadjah Mada University: lead
• Mlati Study Group, Faculty of Medicine, Gadjah Mada University: collaborator

Study Sites (1)

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

Sleman, Special Region of Yogyakarta, 55284, Indonesia

Location

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mochammad Sja'bani, PhD

  Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 21, 2018
• Study Start: July 10, 2017
• Primary Completion: January 12, 2018
• Study Completion: January 19, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

ID (1)