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Completed

NCT Number: NCT05764824

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

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.

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Key information

Conditions

Cognitive Decline Brain Diseases Brain Injuries Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurocognitive Disorders Nutrition, Healthy Trauma, Nervous System Wounds and Injuries

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Brigham

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blueberry powder

Dietary Supplement

20 g per day of blueberry powder

Controlled and matched powder

Other

20 g per day

Primary outcomes

  1. Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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