Rice Vinegar as an Intervention to Lower Blood Pressure in Adults With Prehypertension and 10-year CVD Risk <10% (Rice-vinegar)

July 28, 2019 updated by: Mizkan Holdings Co., Ltd.
This study is to assess the blood pressure lowering effect of rice vinegar when consumed over a 12-week period by healthy adults ages 30-65 years old with prehypertension. Study subjects will be recruited online via ClaimIt software platform and randomized to receive either the active rice vinegar-based drink or placebo and will visit the Endothelix research study site in Houston, Texas, 6 times during the study (Week -2, 0, 4, 8, 12 and 16). Here, subjects will undergo blood pressure monitoring, endothelial function, and laboratory assessments.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Approximately 75 million American adults have hypertension with nearly one in every three adults experiencing a condition known as prehypertension (1). In 2013, more than 360,000 American deaths involved high blood pressure as a primary or co-morbid cause (2). In hypertensive patients, the probability of a first occurrence of heart attack and/or stroke is 70% and 80%, respectively (2). Dietary and lifestyle modifications may help some individuals maintain BP within normal ranges.

Studies of acetic acid, main component of vinegar, conducted with rat and human revealed mechanisms of potential blood pressure lowering (3-7). Also several human clinical trials to assess the efficacy of vinegar on blood pressure have previously been conducted in Japan. Kajimoto et al (2001, 2003) reported that continuous intake of 750 mg of acetic acid daily (approximately 15 mL of vinegar) reduces systolic blood pressure of adults with prehypertension as well as adults with hypertension (8-9). Sadou et al (2006) also reported similar effects with tomato vinegar in adults with prehypertension (750 mg daily acetic acid intake)(10).

The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) published by U.S. Department of Health and Human Services in 2003 defines prehypertension as blood pressure ranging from 120-139 mmHg systolic and 80-89 mmHg diastolic (11). JNC7 states that "prehypertension is not a disease category". Individuals with prehypertension are not candidates for drug therapy, rather they are recommended to practice lifestyle modification to reduce the risk of developing hypertension in the future. The Centers for Disease Control (CDC) shows the same position to JNC7 that a person who have SBP (120-139 mmHg) or DBP (80-89 mmHg) are prehypertension at risk stage (https://www.cdc.gov/bloodpressure/measure.htm). U S Food and Drug Administration (FDA) shows similar position in 21 C.F.R. § 101.74(a)(1) that "Hypertension, or high blood pressure, generally means a systolic blood pressure of greater than 140 millimeters of mercury (mm Hg) or a diastolic blood pressure of greater than 90 mm Hg. Normotension, or normal blood pressure, is a systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.". Recently issued guidance by the American College of Cardiology, the American Heart Association, and other collaborators (ACC/AHA) has emphasized the importance of 10-year CVD risk in categorization of blood pressure, which is calculated using an individual's systolic and diastolic blood pressure values, blood cholesterol levels, and medical history (12). The recommended treatment for an individual with a 10-year CVD risk <10% and blood pressure ≤139 mmHg systolic and ≤89 mmHg diastolic is lifestyle modification and not pharmacologic intervention. The target population for this study is not hypertension as defined by FDA and will align with the blood pressure category of "prehypertension" as defined by JNC7, recognized by CDC, and an additional inclusion criterion of a 10-year CVD risk <10% in recognition of the 2017 ACC/AHA report.

Its potential effects on blood pressure of acetic acid in humans with prehypertension (all clinical trials in Japan) provide a rationale for this evaluation with a Mizkan rice vinegar fruit drink containing 750 mg acetic acid. The purpose of this trial is to investigate the effect of vinegar delivering 750 mg acetic acid on blood pressure over a 12-week period in individuals with prehypertension and a <10% 10-year CVD risk. Additionally, the impact of 750 mg acetic acid as delivered in the vinegar drink on blood markers of the renin-angiotensin-aldosterone system and a marker of endothelial function will be assessed after 12-weeks.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Primary Care Research Group
    • Texas
      • Bellaire, Texas, United States, 77401
        • Endothelix Research Site c/o Bellaire Cardiology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prehypertension (SBP 120-139mmHg and /or DBP 80-89mmHg)
  • Males and females
  • Must be between 30-65 years of age
  • BMI: ≥18.5 kg/m2 and ≤34.9 kg/m2
  • Stable body weight [self-reported weight gain or loss <5kg (11 lbs) in the past 3 months]
  • Agree to comply with the study procedures
  • Able to understand and sign the electronic informed consent
  • Has reliable access to the internet and smartphone, and the necessary skills required to complete study tasks

Exclusion Criteria:

  • SBP ≥140mmHg or SBP <120mmHg
  • Use of tobacco, illegal drugs, or legal drugs known to impact blood pressure (BP), including but not limited to: amphetamine-type stimulants, cannabis, cocaine, heroin and other opioids, and MDMA
  • Significant alcohol consumption (women: >3 drinks a day or >7 drinks a week; men: >4 drinks per day or >14 drinks per week)
  • Women who are pregnant or nursing, and those planning to become pregnant
  • Frequent heartburn, e.g., ≥2 days or more per week
  • Use of anti-hypertensives, anti-depressants, immunosuppressants, drugs for hyperlipidemia, drugs that alter nutrient metabolism, and/or supplements targeting blood pressure reduction, and/or sustained use of NSAIDs within 30 days before randomization
  • Regular use of polyphenol supplements and unwilling to stop use at the time of screening and for the duration of the study
  • Self-identified as "high" consumer of vinegar-containing foods (e.g., 2 days or more per week consumption of a vinegar drink or significant volumes from such categories as salad dressings, pickled foods, etc.)
  • History of chronic medical conditions, including but not limited to Type 1 or 2 diabetes, cardiovascular disease (including previous heart attack or stroke), kidney dysfunction (including chronic kidney disease), cancer
  • An ASCVD 10-year risk score of ≥10% based on the ACC/AHA ASCVD calculator as performed by the Investigator or designee via the ASCVD Risk Estimator website (http://tools.acc.org//ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/)
  • Participation in a clinical research trial within 30 days prior to signing the eIC during screening
  • Clinically significant findings from the laboratory assessments obtained during screening, as assessed by the Investigator or designee
  • Allergy to any component of the vinegar or placebo products
  • Unable to understand the study and undergo the informed consent process despite assistance
  • Having more than one individual from a household participate in the study (to ensure prevention of mistaken consumption of incorrect investigational product)
  • Investigator's discretion, e.g., subject deemed unsuitable or unreliable in follow-up to interaction with Investigator or site staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mizkan rice vinegar with acetic acid
200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar and 750mg acetic acid.
Dietary supplement: Mizkan rice vinegar with acetic acid
200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar and 750mg acetic acid.
PLACEBO_COMPARATOR: Mizkan rice vinegar without acetic acid
200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar that has undergone a freeze-drying process to remove the acetic acid
Dietary supplement: Mizkan rice vinegar without acetic acid
200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar that has undergone a freeze-drying process to remove the acetic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: Weeks 4, 8, 12, and 16
To compare the change from baseline in systolic blood pressure at Weeks 4, 8, 12 (end of treatment), and 16 (end of study), in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks.
Weeks 4, 8, 12, and 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Diastolic Blood Pressure
Time Frame: Weeks 4, 8, 12, and 16
To compare change from the baseline versus Weeks 4, 8, 12, and 16 in diastolic blood pressure in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks.
Weeks 4, 8, 12, and 16
Changes in Corresponding Blood Biomarkers
Time Frame: Week 12
To compare the changes from baseline versus Week 12 in corresponding blood biomarkers (angiotensin II, aldosterone, renin activity, and ACE activity) in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks.
Week 12
Changes in Vascular Reactivity via VENDYS®
Time Frame: Weeks 4, 8, 12, and 16
To compare changes from the baseline versus Weeks 4, 8, 12, and 16 in vascular reactivity to assess the endothelial function via VENDYS® measurements in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks.
Weeks 4, 8, 12, and 16

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Laboratory Values
Time Frame: Week 12
To compare the changes from baseline versus Week 12 in CBC, sodium, potassium, chloride, creatine, eGFR, AST, ALT, GGT, bilirubin, glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, hs-CRP, and oxidized LDL cholesterol), and urinalysis (single void sodium, creatinine) in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks.
Week 12
Assessment of Adverse Events
Time Frame: Week 12
To assess adverse events at Week 12 in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks.
Week 12
Usability of the ClaimIt Software Platform
Time Frame: Week 12
To assess usability of the ClaimIt software platform in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks.
Week 12
Changes in Body Weight and BMI
Time Frame: Weeks 4, 8, 12, and 16
To assess changes from baseline in body weight and BMI (calculated from measured weight and height) will be compared at Weeks 4, 8, 12, and 16 in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks.
Weeks 4, 8, 12, and 16
Changes in Dietary Intake
Time Frame: Week 12
To compare the changes from baseline versus Week 12 in dietary intake in subjects with prehypertension who consume Mizkan rice vinegar active product (acetic acid) daily or placebo (no acetic acid) over a period of 12 weeks
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mizkan Holdings Co., Ltd.

Collaborators

ObvioHealth
Endothelix

Investigators

  • Principal Investigator: Lydia Bazzano, MD, PhD, Tulane University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 11, 2018

Primary Completion (ANTICIPATED)

July 31, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (ACTUAL)

July 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 28, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBVIO_MIZ_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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