What side effects are associated with this type of intervention?

Common treatments for TBI that have antioxidant and anti-inflammatory effects include natural supplements like blueberry powder and Pycnogenol®. Blueberry powder is generally well-tolerated, but some individuals may experience mild gastrointestinal discomfort. Pycnogenol® has shown neuroprotective effects, but potential side effects can include dizziness, gastrointestinal issues, and headaches. Both treatments are considered relatively safe, but further studies are needed to fully understand their long-term safety profiles.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of Traumatic Brain Injury (TBI) that focus on antioxidant and anti-inflammatory effects similar to those being studied with blueberry powder. Research is ongoing in this area, and treatments such as nanocoffee particles and beta-2 receptor antagonists have shown promise in animal models, but they have not yet received FDA approval for clinical use in humans.

What other types of research exist?

Promising alternatives to blueberry powder for TBI patients include garlic, fish oil, and resveratrol due to their antioxidant and anti-inflammatory properties. Probiotics may also be considered for their potential in managing inflammation.

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Other

Blueberry Supplementation for Cognitive Decline

N/A

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 24 weeks post intervention

Awards & highlights

Study Summary

This trial will test if eating blueberry powder for 24 weeks can help memory & cognitive function & lower biomarkers of brain injury in older adults.

Who is the study for?

This trial is for adults aged 65-99 who can visit Brigham and Women's Hospital four times. It's not for those with blueberry allergies, recent major surgery, organ transplants, plans to move from Boston soon, dementia, severe cognitive decline or end-stage renal disease.Check my eligibility

What is being tested?

The study tests if daily consumption of blueberry powder (20g) over 24 weeks improves memory and cognitive functions in older adults compared to a controlled powder without active ingredients.See study design

What are the potential side effects?

Since the intervention involves blueberries which are generally safe, side effects might be minimal but could include potential allergic reactions or gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 24 weeks post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 24 weeks post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 weeks post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks

Secondary outcome measures

Change in cognitive battery test score between baseline and 24 weeks post intervention

Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Blueberry groupActive Control1 Intervention

Blueberry arm

Group II: Control groupPlacebo Group1 Intervention

Control arm

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Traumatic Brain Injury (TBI) often focus on reducing inflammation and oxidative stress, which are key contributors to secondary brain damage. Antioxidants, such as those found in blueberry powder, help neutralize free radicals, thereby reducing oxidative stress and preventing further cellular damage. Anti-inflammatory agents work by inhibiting inflammatory pathways, reducing swelling, and minimizing tissue damage. These mechanisms are crucial for TBI patients as they help to protect brain cells, improve recovery outcomes, and potentially enhance cognitive function.

Neuroprotective effect of Pycnogenol® following traumatic brain injury.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,624 Previous Clinical Trials

11,468,364 Total Patients Enrolled

Media Library

Blueberry powder (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05764824 — N/A

Traumatic Brain Injury Research Study Groups: Control group, Blueberry group

Traumatic Brain Injury Clinical Trial 2023: Blueberry powder Highlights & Side Effects. Trial Name: NCT05764824 — N/A

Blueberry powder (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764824 — N/A

~23 spots leftby Nov 2024

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