AgingNCT04786665
Strawberries, Cognition, and Vascular Health
A study testing Strawberry in people with Aging and Healthy Aging, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy Aging
- What is being tested?
- Strawberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2019to 3 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy men and women 65 years and older
Who cannot join
- stroke or myocardial infarction
- neurological disorders:
- epilepsy,
- multiple sclerosis,
- Parkinson's disease,
- stroke
Show all 12Show fewer
- known metabolic disorders:
- liver,
- renal
- clinically diagnosed diabetes
- drug treatment for lipid reduction or hypertension,
- psychiatric medication use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Aging, Healthy Aging
- Being tested
- Strawberry, Placebo group
- Keywords
- Cognition, Motor control, Vascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrawberryOther
Freeze dried strawberry powder
Placebo groupOther
Comparative placebo powder
| Study group | Role | What they receive |
|---|---|---|
| Strawberry powder | Experimental | Participants consume 1 package of standard strawberry powder (26 g) daily for 8 weeks Receives: Other: Strawberry |
| Placebo group | Placebo comparator | Participants consume 1 package of placebo powder (26 g) daily for 8 weeks Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in processing speed (cognition) at 8 weeks
using Pattern Comparison Processing Speed Test
Measured: 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
Measured: At baseline, at 8 weeks
Change from baseline in working memory (cognition) at 8 weeks
using List Sorting Working Memory Test
Measured: At baseline, at 8 weeks
Change from baseline in episodic memory (cognition) at 8 weeks
using Picture Sequence Memory Test
Measured: At baseline, at 8 weeks
Change from baseline in working memory (cognition) at 8 weeks
using Picture Vocabulary Test; Oral Reading Recognition Test
Measured: At baseline, at 8 weeks
Secondary outcomes (1)
Change from baseline in Vascular health 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.
Measured: At baseline, at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start30 Oct 2019
- Primary completion25 Feb 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirin Hooshmand, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786665
- Sponsor's protocol ID
- 59650A
- Status last verified
- May 2022
- First submitted
- 3 Mar 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40199714
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Strawberries on Cognition, and Vascular and Cardiometabolic Markers in Older Healthy Adults
- ClinicalTrials.gov ID
- NCT04786665
- Acronym / sponsor ID
- 59650A
- Conditions
- Aging, Healthy Aging
- Keywords
- Cognition, Motor control, Vascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Strawberry powder | Experimental | Other: StrawberryParticipants consume 1 package of standard strawberry powder (26 g) daily for 8 weeks |
| Placebo group | Placebo comparator | Other: Placebo groupParticipants consume 1 package of placebo powder (26 g) daily for 8 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy men and women 65 years and older
Key exclusion criteria (12 listed)
- stroke or myocardial infarction
- neurological disorders:
- epilepsy,
- multiple sclerosis,
- Parkinson's disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrawberryFreeze dried strawberry powder | Other | Strawberry powder |
| Placebo groupComparative placebo powder | Other | Placebo group |
Primary outcome
Change from baseline in processing speed (cognition) at 8 weeks
Time frame: At baseline, at 8 weeks
using Pattern Comparison Processing Speed Test
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
Change from baseline in working memory (cognition) at 8 weeks
Time frame: At baseline, at 8 weeks
using List Sorting Working Memory Test
Change from baseline in episodic memory (cognition) at 8 weeks
Time frame: At baseline, at 8 weeks
using Picture Sequence Memory Test
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
1 secondary outcome
Change from baseline in Vascular health at 8 weeks
Time frame: At baseline, at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 40199714Delaney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strawberry in people with Aging and Healthy Aging, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in processing speed (cognition) at 8 weeks (time frame: At baseline, at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04786665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.