Vascular Dilation
Conditions
Keywords
strawberry, diet, vascular function, inflammation
Brief summary
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).
Detailed description
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.
Interventions
approximately 24 strawberries that have been freeze dried into a powder
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
both the control and freeze dried strawberry powders are package with only a code as the identifier
Intervention model description
A randomized, double-blind, crossover dietary intervention trial.
Eligibility
Sex/Gender
MALE
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is willing and able to comply with the study protocols. * Subject is willing to participate in all study procedures * BMI 25.0 - 35 kg/m2
Exclusion criteria
* BMI ≥ 35 kg/m2 * Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000) ≥ 2.8 * Dislike or allergy strawberries * Self-reported use of daily anticoagulation agents including aspirin, NSAIDs * Prescription medications other than on a 6 month self-reported stable dose of medications for lipid lowering and/or hypertension. * Vegan, Vegetarians, food faddists or those consuming a non-traditional diet * Fruit consumption ≥ 3 cups/day * Regular consumption of strawberries (2-3 servings/week) * Vegetable consumption ≥ 4 cups/day * Coffee/tea ≥ 3 cups/day * Dark chocolate ≥ 3 oz/day * Self-reported restriction of physical activity due to a chronic health condition * Self-reported chronic/routine high intensity exercise * Self-reported diabetes * Blood pressure ≥ 140/90 mm Hg * Self-reported renal or liver disease * Self-reported heart disease, which includes cardiovascular events and stroke * Peripheral artery disease Raynaud's syndrome or disease * Inability to properly place or wear the PAT probes or abnormal measurements on pre- screening PAT * Abnormal Metabolic or CBC panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician. * Self-reported cancer within past 5 years * Self-reported malabsorption * Supplement use other than a general formula of vitamins and minerals that meet the RDA * Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment. * Indications of substance or alcohol abuse within the last 3 years * Cannabis use * Current enrollee in a clinical research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Framingham Reactive Hyperemia Index (fRHI) | 4 weeks | fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Th17 cytokines | 4 weeks | 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. |
| insulin like growth factor (IGF) and binding proteins (IGFBP) | 4 weeks | Luminex panel: IGF-1, -2 and IGFBP 1-7 |
| Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase | 4 weeks | soluble form marker of oxidative stress |
| platelet aggregation | 4 weeks | optimal platelet aggregometry using collagen and adp as agonist |
| total nitrate and nitrite | 4 weeks | plasma total nitrate and nitrite |
Other
| Measure | Time frame | Description |
|---|---|---|
| plasma lipids | 4 weeks | clinical lipid panel |
| blood pressure | 4 weeks | systolic and diastolic blood pressure |
Countries
United States
Outcome results
None listed