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

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ClinicalTrials.gov Identifier: NCT03596099
Recruitment Status : Active, not recruiting
First Posted : July 23, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
ObvioHealth
Endothelix
Information provided by (Responsible Party):
Mizkan Holdings Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Prehypertension Dietary Supplement: Mizkan rice vinegar with acetic acid Dietary Supplement: Mizkan rice vinegar without acetic acid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, two-arm, parallel-group, double-blind, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A unique randomization ID number will be assigned by ClaimIt to each enrolled subject and associated with the correct study product kit number; this number will be used throughout the study (includes study execution, safety reporting, compliance with the study product, and efficacy). Both the Mizkan rice vinegar active product (acetic acid) and placebo (no acetic acid) will be labeled identically and will be distinguishable only by the individual subject ID printed on the label.
Primary Purpose: Prevention
Official Title: Rice Vinegar as an Intervention to Lower Blood Pressure in Adults With Prehypertension and 10-year CVD Risk <10%
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596099


Locations
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United States, Georgia
Primary Care Research Group
Atlanta, Georgia, United States, 30312
United States, Texas
Endothelix Research Site c/o Bellaire Cardiology Associates
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
Mizkan Holdings Co., Ltd.
ObvioHealth
Endothelix
Investigators
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Principal Investigator: Lydia Bazzano, MD, PhD Tulane University
Publications:
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
(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
(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
(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

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Responsible Party: Mizkan Holdings Co., Ltd.
ClinicalTrials.gov Identifier: NCT03596099    
Other Study ID Numbers: OBVIO_MIZ_001
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mizkan Holdings Co., Ltd.:
Prehypertension
Rice vinegar
vinegar
acetic acid
Additional relevant MeSH terms:
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Prehypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases
Acetic Acid
Retinol acetate
Anti-Bacterial Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents