Cardiovascular Risk FactorNCT03659695

Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins

A study testing Grape Powder in people with Cardiovascular Risk Factor, run by University of Arizona at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Risk Factor
What is being tested?: Grape Powder
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2020to 13 Feb 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

BMI of 25-36 kg/m2
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

Who cannot join

Allergies to grapes
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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arizona Agricultural Center
Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: Cardioprotective Effects of Freeze Dried Grape Powder Supplementation on Blood Pressure and Plasma Lipids/Lipoproteins: A Pilot Study

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.

Conditions: Cardiovascular Risk Factor
Being tested: Grape Powder, Placebo Powder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Grape PowderDietary supplement
69 g/d freeze dried grape powder
Placebo PowderDietary supplement
69 g/d placebo powder matched for taste and appearance

Study groups in NCT03659695
Study group	Role	What they receive
Grape Powder	Experimental	69 g/d freeze dried grape powder Receives: Dietary Supplement: Grape Powder
Placebo powder	Placebo comparator	69 g/d placebo powder matched for taste and appearance Receives: Dietary Supplement: Placebo Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

LDL-C/non-HDL-C
Measured: 6-8 weeks
Brachial and central blood pressure
systolic and diastolic pressures
Measured: 6-8 weeks

Secondary outcomes (5)

Pulse Wave Velocity (PWV)
Measured: 6-8 weeks
Augmentation Index
augmentation index corrected for heart rate
Measured: 6-8 weeks
Other lipids and lipoproteins
HDL-C, total cholesterol, and triglycerides
Measured: 6-8 weeks
Glucose
fasting blood glucose
Measured: 6-8 weeks
Insulin
fasting blood insulin
Measured: 6-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202013 Feb 2024

First posted6 Sep 2018
Study start1 Apr 2020
Primary completion13 Feb 2024
Study completion13 Feb 2024

Why it stopped: Contract terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
More trials run by University of ArizonaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03659695
Sponsor's protocol ID: Grape Study
Status last verified: Feb 2024
First submitted: 2 Sep 2018
Last updated: 15 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 16046716
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.
PubMed 18948553
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.
PubMed 24040270
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.
PubMed 23596160
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.
PubMed 22785408
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.
PubMed 19087369
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.
PubMed 28045444
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.
PubMed 18805507
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.
PubMed 22810991
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.
PubMed 24832727
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.
PubMed 16030277
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.
PubMed 26699442
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.
PubMed 24459197
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.
PubMed 24239664

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cardiovascular Risk Factor trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardioprotective Effects of Freeze Dried Grape Powder Supplementation on Blood Pressure and Plasma Lipids/Lipoproteins: A Pilot Study
ClinicalTrials.gov ID: NCT03659695
Acronym / sponsor ID: Grape Study
Conditions: Cardiovascular Risk Factor
Study type: Interventional
Recruitment status: TerminatedReason stopped: Contract terminated
Enrolment: 16 participants (actual)
Lead sponsor: University of ArizonaUniversity, hospital or other
Study start: 1 Apr 2020 (actual)
Primary completion: 13 Feb 2024 (actual)
Study completion: 13 Feb 2024 (actual)
First posted: 6 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Grape Powder	Experimental	Dietary Supplement: Grape Powder69 g/d freeze dried grape powder
Placebo powder	Placebo comparator	Dietary Supplement: Placebo Powder69 g/d placebo powder matched for taste and appearance

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

BMI of 25-36 kg/m2
At least one of the following:

Key exclusion criteria (5 listed)

Allergies to grapes
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Grape Powder69 g/d freeze dried grape powder	Dietary supplement	Grape Powder
Placebo Powder69 g/d placebo powder matched for taste and appearance	Dietary supplement	Placebo powder

Primary outcome

LDL-C/non-HDL-C
Time frame: 6-8 weeks
Brachial and central blood pressure
Time frame: 6-8 weeks
systolic and diastolic pressures

5 secondary outcomes

Pulse Wave Velocity (PWV)
Time frame: 6-8 weeks
Augmentation Index
Time frame: 6-8 weeks
Other lipids and lipoproteins
Time frame: 6-8 weeks
Glucose
Time frame: 6-8 weeks
Insulin
Time frame: 6-8 weeks

Results and safety

The study was stopped early (reason given: Contract terminated). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
BackgroundU.S. Department of Health and Human Services and U.S. Department of Agriculture, 2015-2020 Dietary Guidelines for Americans, 2015.
Background: PubMed 16046716Zern 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.
Background: PubMed 18948553Seymour 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.
Background: PubMed 24040270Patki 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.
Background: PubMed 23596160Allam 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.
Background: PubMed 22785408Thandapilly 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.
Background: PubMed 19087369Perez-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.
Background: PubMed 28045444Rasines-Perea Z, Teissedre PL. Grape Polyphenols' Effects in Human Cardiovascular Diseases and Diabetes. Molecules. 2017 Jan 1;22(1):68. doi: 10.3390/molecules22010068.
Background: PubMed 18805507Chaves 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.
Background: PubMed 22810991Barona 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.
Background: PubMed 24832727Zunino 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.
Background: PubMed 16030277Ridker 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.
Individual participant dataSharing planned: No

Related trials for Cardiovascular Risk Factor

Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Grape Powder in people with Cardiovascular Risk Factor, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Contract terminated). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C/non-HDL-C (time frame: 6-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03659695, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.