The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men

Conditions
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Vascular Dilation

Intervention / Treatment
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* Other: freeze dried strawberry powder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized, double-blind, crossover dietary intervention trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freeze dried strawberry powder<br>39g of freeze dried strawberry powder, which represents three daily servings of strawberries. The powder will be mixed in one cup of water. | Other: freeze dried strawberry powder<br>* approximately 24 strawberries that have been freeze dried into a powder<br>|
| Placebo Comparator: control powder<br>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. | Other: freeze dried strawberry powder<br>* approximately 24 strawberries that have been freeze dried into a powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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strawberry, diet, vascular function, inflammation