NCT04763499

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

February 16, 2021

Last Update Submit

May 9, 2023

Conditions

Vascular Dilation

Keywords

strawberry, diet, vascular function, inflammation

Outcome Measures

Primary Outcomes (1)

  • Framingham Reactive Hyperemia Index (fRHI)

    fRHI as a measure of microvascular function will be measured by peripheral arterial tonometry (PAT).

    4 weeks

Secondary Outcomes (5)

  • platelet aggregation

    4 weeks

  • Th17 cytokines

    4 weeks

  • insulin like growth factor (IGF) and binding proteins (IGFBP)

    4 weeks

  • Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase

    4 weeks

  • total nitrate and nitrite

    4 weeks

Other Outcomes (2)

  • blood pressure

    4 weeks

  • plasma lipids

    4 weeks

Study Arms (2)

Freeze dried strawberry powder

EXPERIMENTAL

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

control powder

PLACEBO COMPARATOR

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

Interventions

freeze dried strawberry powderOTHER

approximately 24 strawberries that have been freeze dried into a powder

Freeze dried strawberry powdercontrol powder

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis; Department of Nutrition

Davis, California, 95616, United States

Location

Related Links

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carl L Keen, PhD

    Professor of Nutrition and Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
both the control and freeze dried strawberry powders are package with only a code as the identifier
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: A randomized, double-blind, crossover dietary intervention trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 21, 2021

Study Start

December 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)