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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05024916
Other study ID # STUDY00147614
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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