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| ID | Type | Description | Link |
|---|---|---|---|
| 14-NR-0034 |
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| Name | Class |
|---|---|
| Tufts University | OTHER |
Background:
- Heart disease is the leading cause of death in the United States. Eating fruits and vegetables with chemicals called flavonoids may protect against heart disease and improve blood flow to the heart. They are found in blackcurrant berries. Oils found in fish and mussels called omega-3 fats have also been shown to protect the heart. Researchers want to know if blackcurrant extract and omega-3 fats can improve blood flow, which may increase blood to the heart. They also want to learn about the health of blood vessels and how the heart works.
Objective:
- To learn if blackcurrant extract and omega-3 fats will improve blood flow and make the heart beat stronger.
Eligibility:
- Healthy adults 55 to 75 years old.
Design:
Numerous studies have shown the beneficial effects of fruits, vegetables and omega-3 fatty acids in reducing the risk of cardiovascular disease. The cardioprotective properties may be attributed to the bioactive compounds found in fruits and vegetables called flavonoids. High concentrations of flavonoids with antioxidant activity are found in blackcurrant extract. Flavonoids like omega-3 fatty acids may improve vascular function by increasing the bioavailability of nitric oxide, a potent vasodilator. PCSO-524 (Pernacanaliculus supercritical oil) is of particular interest as a rich source of omega-3 fatty acids derived from the green-lipped mussel. The objectives of this study are to determine the effects of blackcurrant extract, PCSO-524 or the combination of blackcurrant extract & PCSO-524 on endothelial function (flow-mediated brachial artery dilation) and arterial stiffness (cardioankle vascular index) as indicators of cardiovascular risk and atherosclerosis. These indices also provide an assessment of structure and function of the artery. The effects of the supplements on biomarkers of vascular health (endothelial dysfunction, inflammation, injury, oxidative stress, nitric oxide status), lipids and fatty acid profile, and flavonoid profiles will also be determined. In a randomized, double-blind, placebo-controlled trial, 122 healthy older adults (ages 55-75) will be given either blackcurrant extract (1000 mg), PCSO-524 (400 mg), or blackcurrant extract (1000 mg) & PCSO-524 (400 mg) daily for 8 weeks while consuming their usual diet. The study will include 4 visits at 8 week intervals consisting of treatment, washout and placebo phases.
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| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function (flow-mediated brachial artery dilation) and arterial stiffness (cardio-ankle vascular index) | 8 weeks x 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of vascular health (endothelial dysfunction, inflammation, injury, oxidative stress, nitric oxide status), lipids and fatty acid profile, and flavonoid profiles | 8 weeks x 4 |
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EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Marguerite M Engler, Ph.D. | National Institute of Nursing Research (NINR) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11412050 | Background | Joshipura KJ, Hu FB, Manson JE, Stampfer MJ, Rimm EB, Speizer FE, Colditz G, Ascherio A, Rosner B, Spiegelman D, Willett WC. The effect of fruit and vegetable intake on risk for coronary heart disease. Ann Intern Med. 2001 Jun 19;134(12):1106-14. doi: 10.7326/0003-4819-134-12-200106190-00010. | |
| 9126498 | Background |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D006949 | Hyperlipidemias |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Ness AR, Powles JW. Fruit and vegetables, and cardiovascular disease: a review. Int J Epidemiol. 1997 Feb;26(1):1-13. doi: 10.1093/ije/26.1.1. |
| 8105262 | Background | Hertog MG, Feskens EJ, Hollman PC, Katan MB, Kromhout D. Dietary antioxidant flavonoids and risk of coronary heart disease: the Zutphen Elderly Study. Lancet. 1993 Oct 23;342(8878):1007-11. doi: 10.1016/0140-6736(93)92876-u. |
| D009750 | Nutritional and Metabolic Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |