Strawberries, Cognition, and Vascular Health

Not Applicable

Completed

• Conditions: Aging; Healthy Aging
• Interventions: Other: Strawberry; Other: Placebo group

• Registration Number: NCT04786665
• Lead Sponsor: San Diego State University

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.

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 Timeline

• Study Start: 2019-10-30
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-08
• Primary Completion: 2022-02-25
• Status Verified: 2022-05
• Study Completion: 2022-05-03
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Strawberry powder	Strawberry	Participants consume 1 package of standard strawberry powder (26 g) daily for 8 weeks
Placebo group	Placebo group	Participants consume 1 package of placebo powder (26 g) daily for 8 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Vascular health at 8 weeks	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.

Trial Locations

Locations (1)

Shirin Hooshmand; 🇺🇸 San Diego, California, United States