Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-29 @ 8:16 PM
Study NCT ID:
NCT03659695
Status:
TERMINATED
Last Update Posted:
2024-02-15
First Post:
2018-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722782', 'term': 'whole grape extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Contract terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2018-09-02', 'studyFirstSubmitQcDate': '2018-09-02', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C/non-HDL-C', 'timeFrame': '6-8 weeks'}, {'measure': 'Brachial and central blood pressure', 'timeFrame': '6-8 weeks', 'description': 'systolic and diastolic pressures'}], 'secondaryOutcomes': [{'measure': 'Pulse Wave Velocity (PWV)', 'timeFrame': '6-8 weeks'}, {'measure': 'Augmentation Index', 'timeFrame': '6-8 weeks', 'description': 'augmentation index corrected for heart rate'}, {'measure': 'Other lipids and lipoproteins', 'timeFrame': '6-8 weeks', 'description': 'HDL-C, total cholesterol, and triglycerides'}, {'measure': 'Glucose', 'timeFrame': '6-8 weeks', 'description': 'fasting blood glucose'}, {'measure': 'Insulin', 'timeFrame': '6-8 weeks', 'description': 'fasting blood insulin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Risk Factor']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'U.S. Department of Health and Human Services and U.S. Department of Agriculture, 2015-2020 Dietary Guidelines for Americans, 2015.'}, {'pmid': '16046716', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18948553', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24040270', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23596160', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22785408', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19087369', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28045444', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '18805507', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22810991', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24832727', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16030277', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26699442', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24459197', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24239664', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28145414', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Whole food-based dietary interventions have the potential to promote cardiometabolic health via multiple mechanisms, including improvements in blood pressure, bad cholesterol, and other markers of metabolic health. Previous research suggests that grapes have the potential to promote optimal cardiometabolic function by reducing LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few studies have evaluated effects on vascular health following daily grape consumption. We propose to examine the effects of 6-8 weeks of supplementation with freeze dried grape powder (69 g/d; \\~three ¾ cup servings) compared to a control powder without grapes on: 1) bad cholesterol and blood pressure and 2) other measures of cardiometabolic health, including glucose and insulin. We will enroll overweight (BMI 25-36 kg/m2) but otherwise healthy adults with moderately elevated LDL-C (\\>115 mg/dL for women and \\>130 mg/dL for men) and/or blood pressure of120-159/80-99 mm Hg. This will optimize the potential for observing significant changes in these measures of health. We will recruit 20 eligible participants with the expectation that at least 15 will complete the study. The placebo-controlled, crossover study design will allow for a direct comparison of effects within the same participant. We anticipate that the bioactive components of grapes will promote cardiometabolic health via changes in LDL-C and blood pressure. Results from the proposed study would help to clarify how daily grape consumption might promote health and would provide further support for incorporating whole, unprocessed fruit in a healthy dietary pattern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of 25-36 kg/m2\n* At least one of the following:\n\n * LDL-C above 115 mg/dL (women) or above 130 mg/dL (men)\n * Systolic blood pressure of 120-159 mmHg\n * Diastolic blood pressure of 80-99 mmHg\n\nExclusion Criteria:\n\n* Allergies to grapes\n* History of CVD, blood pressure ≥ 160/100 mmHg, kidney disease, diabetes, or inflammatory diseases such as GI disorders and rheumatoid arthritis\n* Use of medications/supplements for elevated lipids, blood pressure, or glucose\n* Chronic use of non-steroidal anti-inflammatory or immunosuppressant drugs\n* Conditions requiring chronic use of steroids'}, 'identificationModule': {'nctId': 'NCT03659695', 'briefTitle': 'Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Cardioprotective Effects of Freeze Dried Grape Powder Supplementation on Blood Pressure and Plasma Lipids/Lipoproteins: A Pilot Study', 'orgStudyIdInfo': {'id': 'Grape Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grape Powder', 'description': '69 g/d freeze dried grape powder', 'interventionNames': ['Dietary Supplement: Grape Powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo powder', 'description': '69 g/d placebo powder matched for taste and appearance', 'interventionNames': ['Dietary Supplement: Placebo Powder']}], 'interventions': [{'name': 'Grape Powder', 'type': 'DIETARY_SUPPLEMENT', 'description': '69 g/d freeze dried grape powder', 'armGroupLabels': ['Grape Powder']}, {'name': 'Placebo Powder', 'type': 'DIETARY_SUPPLEMENT', 'description': '69 g/d placebo powder matched for taste and appearance', 'armGroupLabels': ['Placebo powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Agricultural Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Nutritional Sciences', 'investigatorFullName': 'Ann Skulas-Ray', 'investigatorAffiliation': 'University of Arizona'}}}}