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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
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
 (submitted: February 18, 2021)
Framingham Reactive Hyperemia Index (fRHI) [ Time Frame: 4 weeks ]
fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2021)
  • platelet aggregation [ Time Frame: 4 weeks ]
    optimal platelet aggregometry using collagen and adp as agonist
  • Th17 cytokines [ Time Frame: 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) [ Time Frame: 4 weeks ]
    Luminex panel: IGF-1, -2 and IGFBP 1-7
  • Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase [ Time Frame: 4 weeks ]
    soluble form marker of oxidative stress
  • total nitrate and nitrite [ Time Frame: 4 weeks ]
    plasma total nitrate and nitrite
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 31, 2021)
  • blood pressure [ Time Frame: 4 weeks ]
    systolic and diastolic blood pressure
  • plasma lipids [ Time Frame: 4 weeks ]
    clinical lipid panel
Original Other Pre-specified Outcome Measures
 (submitted: February 18, 2021)
  • blood pressure [ Time Frame: 4 weeks ]
    office blood pressure
  • plasma lipids [ Time Frame: 4 weeks ]
    clinical lipid panel
 
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
Condition  ICMJE Vascular Dilation
Intervention  ICMJE Other: freeze dried strawberry powder
approximately 24 strawberries that have been freeze dried into a powder
Study Arms  ICMJE
  • Experimental: Freeze dried strawberry powder

    39g of freeze dried strawberry powder, which represents three daily servings of strawberries.

    The powder will be mixed in one cup of water.

    Intervention: Other: freeze dried strawberry powder
  • Placebo Comparator: control powder
    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.
    Intervention: Other: freeze dried strawberry powder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2021)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Roberta R Holt, PhD 530-400-5952 rrholt@ucdavis.edu
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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
Principal Investigator: Carl L Keen, PhD Professor of Nutrition and Internal Medicine
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