Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults

Cognitive Decline Clinical Trial

Official title:

Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults: a Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764824
• Other study ID #: 2022P002554
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Brigham and Women's Hospital
• Contact: Luc Djousse, MD, ScD, MPH
• Phone: 617-525-7591
• Email: Ldjousse[@]rics.bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.

Description:

In a randomized, double-blind placebo, controlled design, the investigators will test the effects of 20 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adults aged 65-99 years
• Able to travel to Brigham and Women's Hospital for 4 clinic visits

Exclusion Criteria:

• Known allergies to blueberries
• Unable to abstain from blueberry consumption during the study period
• Inability to provide informed consent
• Planned major surgery during study period or recent major surgery up to 3 months before recruitment
• Organ transplant
• Plan to move out of greater Boston area during the study period
• Diagnosis of dementia, severe cognitive decline, end-stage renal disease, substance abuse, insulin-dependent diabetes mellitus, major cancer excluding non-melanoma skin cancer, and schizophrenia.

Related Conditions & MeSH terms

• Brain Injuries
• Cognitive Decline
• Cognitive Dysfunction

Intervention

Dietary Supplement:
• Blueberry powder
20 g per day of blueberry powder

Other:
• Controlled and matched powder
20 g per day

Locations

Country	Name	City	State
United States	Mass General Brigham	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks	Change will be calculated as difference between plasma NFL concentration measured at 24 weeks and NFL concentration measured at baseline.	Baseline and at 24 weeks after the intervention
Primary	Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks	Change will be calculated as difference between plasma pTau-181 concentration measured at 24 weeks and plasma concentration of pTau-181 measured at baseline	Baseline and at 24 weeks post intervention
Secondary	Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks	Change will be calculated as difference between plasma concentration of GFAB measured at 24 weeks and plasma GFAB concentration measured at baseline	Baseline and at 24 weeks post intervention
Secondary	Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks	Change will be computed as difference between serum concentration of NEFA measured at 24 weeks and serum NEFA concentration measured at baseline	Baseline and 24 weeks post intervention
Secondary	Change in cognitive battery test score between baseline and 24 weeks post intervention	The investigators will use CANTAB (computer-based and interactive software) to complete 8 cognitive battery tests including a) Motor screening task; b) Reaction time; c) Paired associates learning; d) Spatial working memory; e) Pattern recognition memory; f) Delayed matching to sample; g) Rapid visual information processing; and h) Match to sample visual search. The computer automatically calculates a composite score from these 8 tests (a-h) and the investigators will define change in cognitive battery test score as difference in composite score between 24 weeks and baseline.	Baseline and at 24 weeks post intervention