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

NCT ID: NCT03596099

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-11
• Study Completion Date: 2019-10-01

Brief Summary

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.

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.

Conditions

Prehypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Mizkan rice vinegar with acetic acid

200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar and 750mg acetic acid.

Group Type: EXPERIMENTAL

Mizkan rice vinegar with acetic acid

Intervention Type: DIETARY_SUPPLEMENT

200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar and 750mg acetic acid.

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

Group Type: PLACEBO_COMPARATOR

Mizkan rice vinegar without acetic acid

Intervention Type: DIETARY_SUPPLEMENT

200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar that has undergone a freeze-drying process to remove the acetic acid

Interventions

Mizkan rice vinegar with acetic acid

200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar and 750mg acetic acid.

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ObvioHealth

INDUSTRY

Sponsor Role: collaborator

Endothelix

UNKNOWN

Sponsor Role: collaborator

Mizkan Holdings Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lydia Bazzano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tulane University

Locations

Primary Care Research Group

Atlanta, Georgia, United States

Endothelix Research Site c/o Bellaire Cardiology Associates

Bellaire, Texas, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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(8) Kajimoto, O., et al. (2001). Effects of a drink containing vinegar on blood pressure in mildly and moderately hypertensive subjects. J Nutr Food, 2001, 4, 1-14

Reference Type: BACKGROUND

(9) Kajimoto, O., Tayama, K., Hirata, H., Nishimura, A., Tsukamoto, Y. (2003). Hypotensive effects of drinks containing vinegar on high normal blood pressure and milk hypertensive subjects. J Nutr Food, 6(1), 51-68

Reference Type: BACKGROUND

(10) Sadou et al. (2006). Antihypertensive Effect and Safety of a Drink ContainingTomato Vinegar in Case of Long-term Intake for Subjects with High-normal Blood Pressure or Mild Hypertension. Jpn Pharmacol Ther, 34, 6

Reference Type: BACKGROUND

Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

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Other Identifiers

OBVIO_MIZ_001

Identifier Type: -

Identifier Source: org_study_id