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Blueberry Intervention Study for Brain Aging

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05024916
Collaborator
U.S. Highbush Blueberry Council (Other)
65
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Intervention
  • Dietary Supplement: Control
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
The Effect of Blueberry Consumption on Brain Health in Older Adults: in Vivo Measures of Cerebral Antioxidant and Cerebral Blood Flow
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in brain glutathione (GSH) levels [Change from baseline to 3 months]

      Measure of brain GSH with a 3 T MRI scanner

    2. Change in cerebral blood flow (CBF) [Change from baseline to 3 months]

      Measure of CBF with a 3 T MRI scanner

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    In-Young Choi, Ph.D., Professor of Neurology, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT05024916
    Other Study ID Numbers:
    • STUDY00147614
    First Posted:
    Aug 27, 2021
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 30, 2022