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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Prehypertension

In brief

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.

Key facts

Study ID: NCT03596099
Run by: Mizkan Holdings Co., Ltd.
People needed: 130
Starts: 2018-09-11
Expected to finish: 2019-10-01
Last updated by the study team: 2019-07-30

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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