search
Back to results

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

Primary Purpose

Cognitive Decline, Nutrition, Healthy, Brain Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry powder
Controlled and matched powder
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mass General BrighamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Blueberry group

Control group

Arm Description

Blueberry arm

Control arm

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
January 31, 2023
Last Updated
October 24, 2023
Sponsor
Brigham and Women's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05764824
Brief Title
Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults
Official Title
Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults: a Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Nutrition, Healthy, Brain Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blueberry group
Arm Type
Active Comparator
Arm Description
Blueberry arm
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control arm
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry powder
Intervention Description
20 g per day of blueberry powder
Intervention Type
Other
Intervention Name(s)
Controlled and matched powder
Intervention Description
20 g per day
Primary Outcome Measure Information:
Title
Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks
Description
Change will be calculated as difference between plasma NFL concentration measured at 24 weeks and NFL concentration measured at baseline.
Time Frame
Baseline and at 24 weeks after the intervention
Title
Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks
Description
Change will be calculated as difference between plasma pTau-181 concentration measured at 24 weeks and plasma concentration of pTau-181 measured at baseline
Time Frame
Baseline and at 24 weeks post intervention
Secondary Outcome Measure Information:
Title
Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks
Description
Change will be calculated as difference between plasma concentration of GFAB measured at 24 weeks and plasma GFAB concentration measured at baseline
Time Frame
Baseline and at 24 weeks post intervention
Title
Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks
Description
Change will be computed as difference between serum concentration of NEFA measured at 24 weeks and serum NEFA concentration measured at baseline
Time Frame
Baseline and 24 weeks post intervention
Title
Change in cognitive battery test score between baseline and 24 weeks post intervention
Description
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.
Time Frame
Baseline and at 24 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc Djousse, MD, ScD, MPH
Phone
617-525-7591
Email
Ldjousse@rics.bwh.harvard.edu
Facility Information:
Facility Name
Mass General Brigham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Djousse, MD, ScD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs