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Completed

NCT Number: NCT04786665

Strawberries, Cognition, and Vascular Health

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.

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Key information

Conditions

Aging Healthy Aging

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirin Hooshmand

San Diego, California, 92182-7251, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strawberry

Other

Freeze dried strawberry powder

Placebo Group

Other

Comparative placebo powder

Primary outcomes

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

    Time frame: At baseline, at 8 weeks

    using Pattern Comparison Processing Speed Test

  2. 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

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

    Time frame: At baseline, at 8 weeks

    using List Sorting Working Memory Test

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

    Time frame: At baseline, at 8 weeks

    using Picture Sequence Memory Test

  5. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2021
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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