Blueberry Intervention Study for Brain Aging

Brain Aging Clinical Trial

Official title:

The Effect of Blueberry Consumption on Brain Health in Older Adults: in Vivo Measures of Cerebral Antioxidant and Cerebral Blood Flow

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05024916
• Other study ID #: STUDY00147614
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: University of Kansas Medical Center
• Contact: Caitlin Boeckman
• Phone: (913)588-6254
• Email: blueberrystudy[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if increased blueberry intake helps increase brain antioxidant (glutathione) and cerebral blood flow in older adults.

Description:

Consuming blueberries may improve brain health of older adults by increasing the antioxidant levels in the brain to protect nerve cells in the aging brain. Researchers think that there may be a relationship between the brain's antioxidant defense system and blueberry intake due to the high antioxidant content in blueberries.

This study will investigate if blueberry intake may aid in enhancing glutathione levels and cerebral blood flow using special Magnetic Resonance Imaging (MRI) scans.

Participants will be asked to make a total of up to 4 visits to the research site. Participation will last about 3 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

Inclusion Criteria:

• Speak English as the primary language and be able to read and write.

• Good general health with no concomitant diseases

• Low berry consumption (=1 serving/week)

• Cognitively normal (Mini-Mental State Exam Score =24)

• BMI range=18.5-35 kg/m2.

Exclusion Criteria:

• Presence of any central neurological diseases or prior major head trauma with loss of consciousness

• Presence of an active unstable and life-threatening systemic illness

• Presence of major psychiatric disorders within the past 3 years including depression, anxiety, and alcohol or drug abuse

• Presence of diabetes mellitus; metabolic syndrome or uncontrolled hypertension

• Use of psychoactive and investigational medications

• MRI contraindications (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia)

• Blueberry or salicylate allergy

• Pregnancy

Related Conditions & MeSH terms

• Brain Aging

Intervention

Dietary Supplement:
• Intervention
26 g packets of freeze-dried blueberries (equivalent to 1 cup of fresh blueberries) will be given to participants to be consumed daily. Participants will be asked to consume 1 packet per day for 3 months.
• Control
26 g packets of isocaloric carbohydrate-matched powder will be given to participants to be consumed daily. Participants will be asked to consume 1 packet/day for 3 months.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	U.S. Highbush Blueberry Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain glutathione (GSH) levels	Measure of brain GSH with a 3 T MRI scanner	Change from baseline to 3 months
Primary	Change in cerebral blood flow (CBF)	Measure of CBF with a 3 T MRI scanner	Change from baseline to 3 months