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

NCT03596099 | Unknown

• 1 other identifier: OBVIO_MIZ_001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Prehypertension

Keywords

Prehypertension; Rice vinegar; vinegar; acetic acid

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure

  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 Outcomes (3)

• Changes in Diastolic Blood Pressure

  Weeks 4, 8, 12, and 16

• Changes in Corresponding Blood Biomarkers

  Week 12

• Changes in Vascular Reactivity via VENDYS®

  Weeks 4, 8, 12, and 16

Other Outcomes (5)

• Changes in Laboratory Values

  Week 12

• Assessment of Adverse Events

  Week 12

• Usability of the ClaimIt Software Platform

  Week 12

Study Arms (2)

Mizkan rice vinegar with acetic acid

EXPERIMENTAL

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

Dietary Supplement: Mizkan rice vinegar with acetic acid

Mizkan rice vinegar without acetic acid

PLACEBO COMPARATOR

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

Interventions

Mizkan rice vinegar with acetic acid DIETARY_SUPPLEMENT

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

Mizkan rice vinegar with acetic acid

Mizkan rice vinegar without acetic acid 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

Mizkan rice vinegar without acetic acid

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Mizkan Holdings Co., Ltd.: lead
• ObvioHealth: collaborator
• Endothelix: collaborator

Study Sites (2)

Primary Care Research Group

Atlanta, Georgia, 30312, United States

Location

Endothelix Research Site c/o Bellaire Cardiology Associates

Bellaire, Texas, 77401, United States

Location

Related Publications (12)

• 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 BACKGROUND

• Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres 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. No abstract available.

  PMID: 25520374 BACKGROUND

• 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. doi: 10.1271/bbb.90953. Epub 2010 May 7.

  PMID: 20460711 BACKGROUND

• 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-1alpha/PPARgamma 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 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1248/bpb.28.1208.

  PMID: 15997099 BACKGROUND

• 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. doi: 10.1271/bbb.65.2690.

  PMID: 11826965 BACKGROUND

• (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

  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

  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

  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.

  PMID: 12748199 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Prehypertension

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Lydia Bazzano, MD, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, two-arm, parallel-group, double-blind, placebo-controlled

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 23, 2018
• Study Start: September 11, 2018
• Primary Completion: July 31, 2019
• Study Completion: October 1, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)