Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins
NCT ID: NCT03659695
Last Updated: 2024-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
16 participants
INTERVENTIONAL
2020-04-01
2024-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Grape Powder
69 g/d freeze dried grape powder
Grape Powder
69 g/d freeze dried grape powder
Placebo powder
69 g/d placebo powder matched for taste and appearance
Placebo Powder
69 g/d placebo powder matched for taste and appearance
Interventions
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Grape Powder
69 g/d freeze dried grape powder
Placebo Powder
69 g/d placebo powder matched for taste and appearance
Eligibility Criteria
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Inclusion Criteria
* At least one of the following:
* LDL-C above 115 mg/dL (women) or above 130 mg/dL (men)
* Systolic blood pressure of 120-159 mmHg
* Diastolic blood pressure of 80-99 mmHg
Exclusion Criteria
* History of CVD, blood pressure ≥ 160/100 mmHg, kidney disease, diabetes, or inflammatory diseases such as GI disorders and rheumatoid arthritis
* Use of medications/supplements for elevated lipids, blood pressure, or glucose
* Chronic use of non-steroidal anti-inflammatory or immunosuppressant drugs
* Conditions requiring chronic use of steroids
30 Years
65 Years
ALL
Yes
Sponsors
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University of Arizona
OTHER
Responsible Party
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Ann Skulas-Ray
Assistant Professor of Nutritional Sciences
Locations
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University of Arizona Agricultural Center
Tucson, Arizona, United States
Countries
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References
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U.S. Department of Health and Human Services and U.S. Department of Agriculture, 2015-2020 Dietary Guidelines for Americans, 2015.
Zern TL, Wood RJ, Greene C, West KL, Liu Y, Aggarwal D, Shachter NS, Fernandez ML. Grape polyphenols exert a cardioprotective effect in pre- and postmenopausal women by lowering plasma lipids and reducing oxidative stress. J Nutr. 2005 Aug;135(8):1911-7. doi: 10.1093/jn/135.8.1911.
Seymour EM, Singer AA, Bennink MR, Parikh RV, Kirakosyan A, Kaufman PB, Bolling SF. Chronic intake of a phytochemical-enriched diet reduces cardiac fibrosis and diastolic dysfunction caused by prolonged salt-sensitive hypertension. J Gerontol A Biol Sci Med Sci. 2008 Oct;63(10):1034-42. doi: 10.1093/gerona/63.10.1034.
Patki G, Allam FH, Atrooz F, Dao AT, Solanki N, Chugh G, Asghar M, Jafri F, Bohat R, Alkadhi KA, Salim S. Grape powder intake prevents ovariectomy-induced anxiety-like behavior, memory impairment and high blood pressure in female Wistar rats. PLoS One. 2013 Sep 9;8(9):e74522. doi: 10.1371/journal.pone.0074522. eCollection 2013.
Allam F, Dao AT, Chugh G, Bohat R, Jafri F, Patki G, Mowrey C, Asghar M, Alkadhi KA, Salim S. Grape powder supplementation prevents oxidative stress-induced anxiety-like behavior, memory impairment, and high blood pressure in rats. J Nutr. 2013 Jun;143(6):835-42. doi: 10.3945/jn.113.174649. Epub 2013 Apr 17.
Thandapilly SJ, LeMaistre JL, Louis XL, Anderson CM, Netticadan T, Anderson HD. Vascular and cardiac effects of grape powder in the spontaneously hypertensive rat. Am J Hypertens. 2012 Oct;25(10):1070-6. doi: 10.1038/ajh.2012.98. Epub 2012 Jul 12.
Perez-Jimenez J, Saura-Calixto F. Grape products and cardiovascular disease risk factors. Nutr Res Rev. 2008 Dec;21(2):158-73. doi: 10.1017/S0954422408125124.
Rasines-Perea Z, Teissedre PL. Grape Polyphenols' Effects in Human Cardiovascular Diseases and Diabetes. Molecules. 2017 Jan 1;22(1):68. doi: 10.3390/molecules22010068.
Chaves AA, Joshi MS, Coyle CM, Brady JE, Dech SJ, Schanbacher BL, Baliga R, Basuray A, Bauer JA. Vasoprotective endothelial effects of a standardized grape product in humans. Vascul Pharmacol. 2009 Jan-Feb;50(1-2):20-6. doi: 10.1016/j.vph.2008.08.004. Epub 2008 Sep 7.
Barona J, Aristizabal JC, Blesso CN, Volek JS, Fernandez ML. Grape polyphenols reduce blood pressure and increase flow-mediated vasodilation in men with metabolic syndrome. J Nutr. 2012 Sep;142(9):1626-32. doi: 10.3945/jn.112.162743. Epub 2012 Jul 18.
Zunino SJ, Peerson JM, Freytag TL, Breksa AP, Bonnel EL, Woodhouse LR, Storms DH. Dietary grape powder increases IL-1beta and IL-6 production by lipopolysaccharide-activated monocytes and reduces plasma concentrations of large LDL and large LDL-cholesterol particles in obese humans. Br J Nutr. 2014 Aug 14;112(3):369-80. doi: 10.1017/S0007114514000890. Epub 2014 May 15.
Ridker PM, Rifai N, Cook NR, Bradwin G, Buring JE. Non-HDL cholesterol, apolipoproteins A-I and B100, standard lipid measures, lipid ratios, and CRP as risk factors for cardiovascular disease in women. JAMA. 2005 Jul 20;294(3):326-33. doi: 10.1001/jama.294.3.326.
Jacobson TA, Maki KC, Orringer CE, Jones PH, Kris-Etherton P, Sikand G, La Forge R, Daniels SR, Wilson DP, Morris PB, Wild RA, Grundy SM, Daviglus M, Ferdinand KC, Vijayaraghavan K, Deedwania PC, Aberg JA, Liao KP, McKenney JM, Ross JL, Braun LT, Ito MK, Bays HE, Brown WV, Underberg JA; NLA Expert Panel. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2. J Clin Lipidol. 2015 Nov-Dec;9(6 Suppl):S1-122.e1. doi: 10.1016/j.jacl.2015.09.002. Epub 2015 Sep 18.
McEniery CM, Cockcroft JR, Roman MJ, Franklin SS, Wilkinson IB. Central blood pressure: current evidence and clinical importance. Eur Heart J. 2014 Jul;35(26):1719-25. doi: 10.1093/eurheartj/eht565. Epub 2014 Jan 23.
Ben-Shlomo Y, Spears M, Boustred C, May M, Anderson SG, Benjamin EJ, Boutouyrie P, Cameron J, Chen CH, Cruickshank JK, Hwang SJ, Lakatta EG, Laurent S, Maldonado J, Mitchell GF, Najjar SS, Newman AB, Ohishi M, Pannier B, Pereira T, Vasan RS, Shokawa T, Sutton-Tyrell K, Verbeke F, Wang KL, Webb DJ, Willum Hansen T, Zoungas S, McEniery CM, Cockcroft JR, Wilkinson IB. Aortic pulse wave velocity improves cardiovascular event prediction: an individual participant meta-analysis of prospective observational data from 17,635 subjects. J Am Coll Cardiol. 2014 Feb 25;63(7):636-646. doi: 10.1016/j.jacc.2013.09.063. Epub 2013 Nov 13.
Woerdeman J, van Poelgeest E, Ket JCF, Eringa EC, Serne EH, Smulders YM. Do grape polyphenols improve metabolic syndrome components? A systematic review. Eur J Clin Nutr. 2017 Dec;71(12):1381-1392. doi: 10.1038/ejcn.2016.227. Epub 2017 Feb 1.
Other Identifiers
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Grape Study
Identifier Type: -
Identifier Source: org_study_id
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