Blueberry Intervention Study for Brain Aging

July 6, 2023 updated by: In-Young Choi, Ph.D., University of Kansas Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • In-Young Choi, PhD
        • Sub-Investigator:
          • Debra Sullivan, PhD
        • Sub-Investigator:
          • Phil Lee, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years to 87 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants will receive the dietary intervention. Participants will take 1 serving of blueberries/day.
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.
Other Names:
  • Freeze-dried blueberries
Active Comparator: Control
Participants will receive a placebo. Participants will take 1 serving of placebo/day.
Dietary supplement: 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.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brain glutathione (GSH) levels
Time Frame: Change from baseline to 3 months
Measure of brain GSH with a 3 T MRI scanner
Change from baseline to 3 months
Change in cerebral blood flow (CBF)
Time Frame: Change from baseline to 3 months
Measure of CBF with a 3 T MRI scanner
Change from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

U.S. Highbush Blueberry Council

Investigators

  • Principal Investigator: In-Young Choi, PhD, Department of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00147614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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