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lack of recruiting progress
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The overall objective of this proposed trial is to examine the vascular protective effects provided by the daily consumption of 39g of freeze dried strawberry powder (FDSP) for four weeks. The study population will be older men (60-80 years of age).
The proposed project will determine the influence of short-term FDSP intake on microvascular function in older men (60-80 years of age). The Framingham reactive hyperemia index (fRHI) will be used as a measure of microvascular function, and will be measured using peripheral arterial tonometry (PAT; EndoPAT200). Secondary outcomes will assess circulating levels of nitrate and nitrite, insulin-like growth factor (IGF), inflammatory cytokines, NADPH oxidase, platelet aggregation, plasma lipids and blood pressure. This suite of markers will provide insight on physiological outcomes and risk factors associated with CVD development, and the metabolic and signaling pathways that influence them. To accomplish the above, after a 4 week run in period of no powder intake, twenty men (60-80 years of age) will be randomly assigned to consume 39 g of FDSP or a control powder for four weeks in a randomized, double-blind, controlled crossover study. This study design will compare the short-term (four week) response of FDSP intake to an isocaloric control powder that provides no polyphenols, as well as to their habitual diet where no powder was consumed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freeze dried strawberry powder | Experimental | 39g of freeze dried strawberry powder, which represents three daily servings of strawberries. The powder will be mixed in one cup of water. |
|
| control powder | Placebo Comparator | 39 g of a powder that matches the sugar and caloric content of the experimental powder. The powder will be mixed in one cup of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| freeze dried strawberry powder | Other | approximately 24 strawberries that have been freeze dried into a powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Framingham Reactive Hyperemia Index (fRHI) | fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| platelet aggregation | optimal platelet aggregometry using collagen and adp as agonist | 4 weeks |
| Th17 cytokines | TH17 Luminex panel: Interleukin (IL)-1b, IL-4, IL-6, IL-10, IL-17a, IL-21, IL-22, IL-23, IL-31, IL-33, IFNgamma, TNFalpha, IL-17f. |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | systolic and diastolic blood pressure | 4 weeks |
| plasma lipids | clinical lipid panel | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl L Keen, PhD | Professor of Nutrition and Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis; Department of Nutrition | Davis | California | 95616 | United States |
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| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A randomized, double-blind, crossover dietary intervention trial.
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both the control and freeze dried strawberry powders are package with only a code as the identifier
| 4 weeks |
| insulin like growth factor (IGF) and binding proteins (IGFBP) | Luminex panel: IGF-1, -2 and IGFBP 1-7 | 4 weeks |
| Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase | soluble form marker of oxidative stress | 4 weeks |
| total nitrate and nitrite | plasma total nitrate and nitrite | 4 weeks |