Atlanta, Georgia 30312

  • Prehypertension

Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

OBVIO_MIZ_001


NCT ID:

NCT03596099


Secondary ID:


Study Acronym:

Rice-vinegar


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

30 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mizkan Holdings Co., Ltd.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

130


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lydia Bazzano, MD, PhD
Principal Investigator
Tulane University

Study Dates

Start Date:September 11, 2018
Completion Date:October 1, 2019
Completion Type:Anticipated
Primary Completion Date:July 31, 2019
Primary Completion Type:Anticipated
Verification Date:July 2019
Last Changed Date:July 28, 2019
First Received Date:July 6, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Changes in Vascular Reactivity via VENDYS®
Time Frame:Weeks 4, 8, 12, and 16
Safety Issues:False
Description: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 pl
Outcome Type:Secondary Outcome
Measure:Changes in Corresponding Blood Biomarkers
Time Frame:Week 12
Safety Issues:False
Description: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 pl
Outcome Type:Secondary Outcome
Measure:Changes in Diastolic Blood Pressure
Time Frame:Weeks 4, 8, 12, and 16
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in Systolic Blood Pressure
Time Frame:Weeks 4, 8, 12, and 16
Safety Issues:False
Description: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) ove

Study Interventions

Intervention Type:Dietary Supplement
Name:Mizkan rice vinegar without acetic acid
Description:200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar that has undergone a freeze-drying process to remove the acetic acid
Arm Name:Mizkan rice vinegar without acetic acid
Intervention Type:Dietary Supplement
Name:Mizkan rice vinegar with acetic acid
Description:200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar and 750mg acetic acid.
Arm Name:Mizkan rice vinegar with acetic acid

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Mizkan rice vinegar without acetic acid
Description:200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar that has undergone a freeze-drying process to remove the acetic acid
Study Arm Type:Experimental
Arm Name:Mizkan rice vinegar with acetic acid
Description:200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar and 750mg acetic acid.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Mizkan Holdings Co., Ltd.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:ObvioHealth

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension Guideline. Ann Intern Med. 2018 Mar 6;168(5):351-358. doi: 10.7326/M17-3203. Epub 2018 Jan 23.
PMID:29357392
Reference Type:Reference
Citation: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. Epub 2003 May 14. Erratum in: JAMA. 2003 Jul 9;290(2):197.
PMID:12748199
Reference Type:Reference
Citation:(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:Reference
Citation:(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:Reference
Citation:(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:Reference
Citation:Kondo S, Tayama K, Tsukamoto Y, Ikeda K, Yamori Y. Antihypertensive effects of acetic acid and vinegar on spontaneously hypertensive rats. Biosci Biotechnol Biochem. 2001 Dec;65(12):2690-4.
PMID:11826965
Reference Type:Reference
Citation:Honsho S, Sugiyama A, Takahara A, Satoh Y, Nakamura Y, Hashimoto K. A red wine vinegar beverage can inhibit the renin-angiotensin system: experimental evidence in vivo. Biol Pharm Bull. 2005 Jul;28(7):1208-10.
PMID:15997099
Reference Type:Reference
Citation:Mitrou P, Petsiou E, Papakonstantinou E, Maratou E, Lambadiari V, Dimitriadis P, Spanoudi F, Raptis SA, Dimitriadis G. Vinegar Consumption Increases Insulin-Stimulated Glucose Uptake by the Forearm Muscle in Humans with Type 2 Diabetes. J Diabetes Res. 2015;2015:175204. doi: 10.1155/2015/175204. Epub 2015 May 6.
PMID:26064976
Reference Type:Reference
Citation:Na L, Chu X, Jiang S, Li C, Li G, He Y, Liu Y, Li Y, Sun C. Vinegar decreases blood pressure by down-regulating AT1R expression via the AMPK/PGC-1α/PPARγ pathway in spontaneously hypertensive rats. Eur J Nutr. 2016 Apr;55(3):1245-53. doi: 10.1007/s00394-015-0937-7. Epub 2015 Oct 18.
PMID:26476634
Reference Type:Reference
Citation:Sakakibara S, Murakami R, Takahashi M, Fushimi T, Murohara T, Kishi M, Kajimoto Y, Kitakaze M, Kaga T. Vinegar intake enhances flow-mediated vasodilatation via upregulation of endothelial nitric oxide synthase activity. Biosci Biotechnol Biochem. 2010;74(5):1055-61. Epub 2010 May 7.
PMID:20460711
Reference Type:Reference
Citation: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.
PMID:25520374
Reference Type:Reference
Citation:Merai R, Siegel C, Rakotz M, Basch P, Wright J, Wong B; DHSc, Thorpe P. CDC Grand Rounds: A Public Health Approach to Detect and Control Hypertension. MMWR Morb Mortal Wkly Rep. 2016 Nov 18;65(45):1261-1264. doi: 10.15585/mmwr.mm6545a3.
PMID:27855138

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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