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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05764824
Collaborator
(none)
60
2
20

Study Details

Study Description

Brief Summary

This study will test whether consuming blueberry powder 25g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Blueberry powder
  • Other: Controlled and matched powder
N/A

Detailed Description

In a randomized, double-blind placebo, controlled design, the investigators will test the effects of 25 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults: a Randomized Placebo-controlled Trial
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Blueberry group

Blueberry arm

Dietary Supplement: Blueberry powder
25 g per day of blueberry powder

Placebo Comparator: Control group

Control arm

Other: Controlled and matched powder
25 g per day

Outcome Measures

Primary Outcome Measures

  1. Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks [Baseline and at 24 weeks after the intervention]

    Change will be calculated as difference between plasma NFL concentration measured at 24 weeks and NFL concentration measured at baseline.

  2. Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks [Baseline and at 24 weeks post intervention]

    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

  1. Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks [Baseline and at 24 weeks post intervention]

    Change will be calculated as difference between plasma concentration of GFAB measured at 24 weeks and plasma GFAB concentration measured at baseline

  2. Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks [Baseline and 24 weeks post intervention]

    Change will be computed as difference between serum concentration of NEFA measured at 24 weeks and serum NEFA concentration measured at baseline

  3. Change in cognitive battery test score between baseline and 24 weeks post intervention [Baseline and at 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luc Djousse, Lead Investigator and Director of Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05764824
Other Study ID Numbers:
  • 2022P002554
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Mar 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2023