The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men
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ClinicalTrials.gov Identifier: NCT04763499 |
Recruitment Status :
Recruiting
First Posted : February 21, 2021
Last Update Posted : February 18, 2022
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Sponsor:
University of California, Davis
Information provided by (Responsible Party):
University of California, Davis
Tracking Information | |||||
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First Submitted Date ICMJE | February 16, 2021 | ||||
First Posted Date ICMJE | February 21, 2021 | ||||
Last Update Posted Date | February 18, 2022 | ||||
Actual Study Start Date ICMJE | December 1, 2021 | ||||
Estimated Primary Completion Date | March 31, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Framingham Reactive Hyperemia Index (fRHI) [ Time Frame: 4 weeks ] fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men | ||||
Official Title ICMJE | The Influence of Daily Strawberry Intake on Vascular Health in Elderly Men | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: A randomized, double-blind, crossover dietary intervention trial. Masking: Double (Participant, Investigator)Masking Description: both the control and freeze dried strawberry powders are package with only a code as the identifier Primary Purpose: Prevention
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Condition ICMJE | Vascular Dilation | ||||
Intervention ICMJE | Other: freeze dried strawberry powder
approximately 24 strawberries that have been freeze dried into a powder
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||
Estimated Primary Completion Date | March 31, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04763499 | ||||
Other Study ID Numbers ICMJE | 1567320 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University of California, Davis | ||||
Original Responsible Party | Carl L. Keen, PhD, University of California, Davis, Professor of Nutrition and Internal Medicine | ||||
Current Study Sponsor ICMJE | University of California, Davis | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of California, Davis | ||||
Verification Date | February 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |