NCT04786665

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

2.3 years

First QC Date

March 3, 2021

Last Update Submit

May 3, 2022

Conditions

Keywords

CognitionMotor controlVascular health

Outcome Measures

Primary Outcomes (5)

  • Change from baseline in processing speed (cognition) at 8 weeks

    using Pattern Comparison Processing Speed Test

    At baseline, at 8 weeks

  • Change from baseline in executive function (cognition) 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

    using List Sorting Working Memory Test

    At baseline, at 8 weeks

  • Change from baseline in episodic memory (cognition) at 8 weeks

    using Picture Sequence Memory Test

    At baseline, at 8 weeks

  • Change from baseline in working memory (cognition) at 8 weeks

    using Picture Vocabulary Test; Oral Reading Recognition Test

    At baseline, at 8 weeks

Secondary Outcomes (1)

  • Change from baseline in Vascular health at 8 weeks

    At baseline, at 8 weeks

Study Arms (2)

Strawberry powder

EXPERIMENTAL

Participants consume 1 package of standard strawberry powder (26 g) daily for 8 weeks

Other: Strawberry

Placebo group

PLACEBO COMPARATOR

Participants consume 1 package of placebo powder (26 g) daily for 8 weeks

Other: Placebo group

Interventions

Freeze dried strawberry powder

Strawberry powder

Comparative placebo powder

Placebo group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy men and women 65 years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirin Hooshmand

San Diego, California, 92182-7251, United States

Location

Related Publications (1)

  • Delaney K, Tsang M, Kern M, Rayo VU, Jason N, Hong MY, Liu C, Hooshmand S. Strawberries modestly improve cognition and cardiovascular health in older adults. Nutr Metab Cardiovasc Dis. 2025 Aug;35(8):104018. doi: 10.1016/j.numecd.2025.104018. Epub 2025 Mar 18.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 8, 2021

Study Start

October 30, 2019

Primary Completion

February 25, 2022

Study Completion

May 3, 2022

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations