Strawberries, Cognition, and Vascular Health

May 3, 2022 updated by: Shirin Hooshmand, San Diego State University

Impact of Strawberries on Cognition, and Vascular and Cardiometabolic Markers in Older Healthy Adults

The primary objective of this study is to investigate the effects of strawberries on cognitive responses, motor control function, and vascular and cardiometabolic risk markers in healthy older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To achieve the objectives, 40 healthy men and women ≥65 years of age will consume 26 g of freeze-dried strawberries in the form of a drink-mix daily for 8 wk. Using a randomized crossover study design, the effects will be compared to the effects of 8 wk intake of a placebo drink-mix (with a 4 wk wash-out period between trials). Cognitive function measurements will be performed at baseline and 8 wk. Additionally, at each timepoint, flow-mediated vasodilation and blood pressure will be measured followed by collection of fasting blood samples to assess glucose, insulin, blood lipids (free fatty acids, triacylglycerol, total cholesterol, LDL cholesterol, and HDL cholesterol), inflammatory markers (interleukins 6 and 18), and markers of oxidative stress (oxidized LDL-C and malondialdehyde).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92182-7251
        • Shirin Hooshmand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women 65 years and older

Exclusion Criteria:

  • stroke or myocardial infarction
  • neurological disorders:
  • epilepsy,
  • multiple sclerosis,
  • Parkinson's disease,
  • stroke
  • known metabolic disorders:
  • liver,
  • renal
  • clinically diagnosed diabetes
  • drug treatment for lipid reduction or hypertension,
  • psychiatric medication use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Strawberry powder
Participants consume 1 package of standard strawberry powder (26 g) daily for 8 weeks
Other: Strawberry
Freeze dried strawberry powder
PLACEBO_COMPARATOR: Placebo group
Participants consume 1 package of placebo powder (26 g) daily for 8 weeks
Other: Placebo group
Comparative placebo powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in processing speed (cognition) at 8 weeks
Time Frame: At baseline, at 8 weeks
using Pattern Comparison Processing Speed Test
At baseline, at 8 weeks
Change from baseline in executive function (cognition) at 8 weeks
Time Frame: At baseline, at 8 weeks
using Dimensional Change Card Sort Test; Flanker Inhibitory Control and Attention Test
At baseline, at 8 weeks
Change from baseline in working memory (cognition) at 8 weeks
Time Frame: At baseline, at 8 weeks
using List Sorting Working Memory Test
At baseline, at 8 weeks
Change from baseline in episodic memory (cognition) at 8 weeks
Time Frame: At baseline, at 8 weeks
using Picture Sequence Memory Test
At baseline, at 8 weeks
Change from baseline in working memory (cognition) at 8 weeks
Time Frame: At baseline, at 8 weeks
using Picture Vocabulary Test; Oral Reading Recognition Test
At baseline, at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Vascular health at 8 weeks
Time Frame: At baseline, at 8 weeks
to better understand how changes in the gut microbiota through fruit consumption are linked to changes in health outcomes, we will assess endothelial function via flow-mediated vasodilation and risk factors for cardiometabolic dysfunction in fasting blood samples collected at baseline and after 8 weeks.
At baseline, at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2019

Primary Completion (ACTUAL)

February 25, 2022

Study Completion (ACTUAL)

May 3, 2022

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (ACTUAL)

March 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 59650A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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