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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05764824
Other study ID # 2022P002554
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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