Prehypertension Clinical Trial
— Rice-vinegarOfficial title:
Rice Vinegar as an Intervention to Lower Blood Pressure in Adults With Prehypertension and 10-year CVD Risk <10%
Verified date | July 2019 |
Source | Mizkan Holdings Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 130 |
Est. completion date | October 1, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Primary Care Research Group | Atlanta | Georgia |
United States | Endothelix Research Site c/o Bellaire Cardiology Associates | Bellaire | Texas |
Lead Sponsor | Collaborator |
---|---|
Mizkan Holdings Co., Ltd. | Endothelix, ObvioHealth |
United States,
(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
(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
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. 2016 Feb 23;133(8):e417. Circulation. 2015 Jun 16;131(24):e535. — View 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-1a/PPAR? 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. — View 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in Laboratory Values | 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. | Week 12 | |
Other | Assessment of Adverse Events | 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. | Week 12 | |
Other | Usability of the ClaimIt Software Platform | 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. | Week 12 | |
Other | Changes in Body Weight and BMI | 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. | Weeks 4, 8, 12, and 16 | |
Other | Changes in Dietary Intake | 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 | Week 12 | |
Primary | 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 | Changes in Diastolic Blood Pressure | 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. | Weeks 4, 8, 12, and 16 | |
Secondary | Changes in Corresponding Blood Biomarkers | 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. | Week 12 | |
Secondary | Changes in Vascular Reactivity via VENDYS® | 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. | Weeks 4, 8, 12, and 16 |
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