Status:
TERMINATED
The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men
Lead Sponsor:
University of California, Davis
Conditions:
Vascular Dilation
Eligibility:
MALE
60-80 years
Phase:
NA
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 p...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04763499
Start Date
December 1 2021
End Date
December 31 2022
Last Update
May 11 2023
Active Locations (1)
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1
University of California, Davis; Department of Nutrition
Davis, California, United States, 95616