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| ID | Type | Description | Link |
|---|---|---|---|
| 15-NR-0085 |
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Background:
- Heart disease is the leading cause of death and disabilities in the United States. Diets high in fruits and vegetables may reduce the risk of heart disease. Fruits, including red tart cherries and purple aroniaberries, may be especially beneficial. Researchers want to know how tart cherry and aroniaberry extracts affect heart health.
Objective:
- To study the benefits of tart cherry and aroniaberry extract on vascular function and other measures. These include inflammation, oxidation, and cholesterol.
Eligibility:
- Men and post-menopausal women ages 55 70 in good health and with normal or slightly high blood pressure or cholesterol.
Design:
Cardiovascular disease (CVD) continues to be the leading cause of death and disability worldwide. Cardiovascular disease can be age-related in both onset and progression. The aging process causes failure in protective vascular mechanisms leading to pathophysiological changes and increased risk of CVD. Heart healthy strategies including consumption of diets rich in fruits and vegetables reduce risk and prevent CVD. There is growing experimental evidence that certain fruits and berries including, cherries and aroniaberries, may be cardioprotective due to their antioxidant and vasodilatory properties, and beneficial modulation of immune function and inflammation. However, there are limited human studies that have examined these effects. In older adults, vascular aging predominantly includes increased arterial stiffness and endothelial dysfunction. Oxidative stress and inflammation are also linked to the aging process. Therefore, this study will investigate the effects of tart cherry and aroniaberry supplementation on endothelial function (flow-mediated brachial artery dilation) and arterial stiffness (cardio-ankle vascular index) as indicators of cardiovascular risk and atherosclerosis. These measurements also provide an assessment of arterial structure and function. Biomarkers of endothelial dysfunction, inflammation, vascular injury, oxidation, lipids, as well as flavonoid and phenolic acid profiles will also be examined. Importantly, the role of genetics and its environmental interactions as causal factors in CVD are not completely understood. There is also limited data on the plasma proteome and the changes in physiological processes that may result from interventions with diet or nutrients. This study will explore the association between responses to tart cherry or aroniaberry supplementation and single nucleotide polymorphisms (SNPs) in loci related to the study s outcomes and to the risk of CVD. Moreover, the association between these two supplements and a proteomic panel of plasma proteins involved in several physiological pathways and CVD will also be investigated. In a randomized, double-blind, placebo-controlled, crossover clinical trial, 96 healthy older adults (ages 55-70) will be given tart cherry alternating with aroniaberry supplementation daily for 3 weeks each while on their usual diet. This study will include an initial screening visit followed by 6 visits at 3 week intervals consisting of treatment, washout and placebo periods. This investigation will provide important information on the role of flavonoidrich nutrients and their effect on arterial structure and function. Relating genomic and proteomic signatures to the outcomes of this study will be useful in developing future therapeutic strategies to lower CVD risk.
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| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function | Every 3 weeks over 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness, biomarkers of endothelial dysfunction, inflammation, vascular injury, oxidation, lipids, nitric oxide status, flavonoid and phenolic acid profiles. | Every 3 weeks over 15 weeks | |
| Proteomic panel of plasma proteins | Every 3 weeks over 15 weeks |
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An Associate Investigator will examine participants and determine their eligibility according to the inclusion and exclusion criteria as documented by the eligibility checklist.
EXCLUSION CRITERIA:
be clinically significant)
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| Name | Affiliation | Role |
|---|---|---|
| Mary B Engler, Ph.D. | National Institute of Nursing Research (NINR) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15190043 | Background | Engler MB, Engler MM, Chen CY, Malloy MJ, Browne A, Chiu EY, Kwak HK, Milbury P, Paul SM, Blumberg J, Mietus-Snyder ML. Flavonoid-rich dark chocolate improves endothelial function and increases plasma epicatechin concentrations in healthy adults. J Am Coll Nutr. 2004 Jun;23(3):197-204. doi: 10.1080/07315724.2004.10719361. | |
| 24552647 |
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| Nutrigenomics | Every 3 weeks over 15 weeks |
| Tresserra-Rimbau A, Rimm EB, Medina-Remon A, Martinez-Gonzalez MA, de la Torre R, Corella D, Salas-Salvado J, Gomez-Gracia E, Lapetra J, Aros F, Fiol M, Ros E, Serra-Majem L, Pinto X, Saez GT, Basora J, Sorli JV, Martinez JA, Vinyoles E, Ruiz-Gutierrez V, Estruch R, Lamuela-Raventos RM; PREDIMED Study Investigators. Inverse association between habitual polyphenol intake and incidence of cardiovascular events in the PREDIMED study. Nutr Metab Cardiovasc Dis. 2014 Jun;24(6):639-47. doi: 10.1016/j.numecd.2013.12.014. Epub 2014 Jan 22. |
| 20576649 | Background | Ungvari Z, Kaley G, de Cabo R, Sonntag WE, Csiszar A. Mechanisms of vascular aging: new perspectives. J Gerontol A Biol Sci Med Sci. 2010 Oct;65(10):1028-41. doi: 10.1093/gerona/glq113. Epub 2010 Jun 24. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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