Strawberries, Cognition, and Vascular Health

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786665
• Other study ID #: 59650A
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: May 3, 2022

Study information

• Verified date: May 2022
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 3, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Healthy Aging

Intervention

Other:
• Strawberry
Freeze dried strawberry powder
• Placebo group
Comparative placebo powder

Locations

Country	Name	City	State
United States	Shirin Hooshmand	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in processing speed (cognition) at 8 weeks	using Pattern Comparison Processing Speed Test	At baseline, at 8 weeks
Primary	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
Primary	Change from baseline in working memory (cognition) at 8 weeks	using List Sorting Working Memory Test	At baseline, at 8 weeks
Primary	Change from baseline in episodic memory (cognition) at 8 weeks	using Picture Sequence Memory Test	At baseline, at 8 weeks
Primary	Change from baseline in working memory (cognition) at 8 weeks	using Picture Vocabulary Test; Oral Reading Recognition Test	At baseline, at 8 weeks
Secondary	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.	At baseline, at 8 weeks