Blueberry Intervention Study for Brain Aging

NCT05024916 | Completed

• 1 other identifier: STUDY00147614
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Aging

Outcome Measures

Primary Outcomes (2)

• Change in brain glutathione (GSH) levels

  Measure of brain GSH with a 3 T MRI scanner

  Change from baseline to 3 months

• Change in cerebral blood flow (CBF)

  Measure of CBF with a 3 T MRI scanner

  Change from baseline to 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive the dietary intervention. Participants will take 1 serving of blueberries/day.

Dietary Supplement: Intervention

Control

ACTIVE COMPARATOR

Participants will receive a placebo. Participants will take 1 serving of placebo/day.

Dietary Supplement: Control

Interventions

Intervention DIETARY_SUPPLEMENT

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.

Also known as: Freeze-dried blueberries

Intervention

Control DIETARY_SUPPLEMENT

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.

Also known as: Placebo

Control

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• U.S. Highbush Blueberry Council: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• In-Young Choi, PhD

  Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: June 1, 2022
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)