Blueberries + Exercise for Cognitive Impairment

Overseen By David C Nieman, DrPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Appalachian State University

Must not be taking: Cognition drugs

Disqualifiers: Diabetes, Uncontrolled cardiovascular, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 64

Duration: 12 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This NIH project will examine the effects of routine flavonoid-rich blueberry intake (12-weeks), combined with or in the absence of regular moderate exercise, on cognitive function in a clinical population of older participants identified as experiencing age-related cognitive changes. This project's hypothesis is that the combination of flavonoid-rich diet and routine physical activity may potentiate cognitive benefits and reduce cognitive decline in an aging population, via mechanisms mediated by the gut microbiome.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use any prescription or over-the-counter drugs intended to support cognition or with known cognitive side effects. Other medications or supplements may also be restricted if the study clinician believes they could interfere with the study.

What data supports the effectiveness of the treatment Blueberry, Exercise, Physical Activity, Workout, Fitness Training for cognitive impairment?

Research shows that blueberries, which are rich in compounds called anthocyanins, can improve memory and cognitive function in older adults. Studies have found that regular blueberry consumption can enhance memory performance and reduce risk factors for dementia, suggesting potential benefits for cognitive health. ^{1 2 3 4 5}

Is the combination of blueberries and exercise safe for humans?

Research suggests that consuming blueberries is generally safe for humans and may even offer health benefits like reducing inflammation and improving cognitive function. Exercise is also widely recognized as safe and beneficial for most people, though strenuous workouts can increase inflammation temporarily. Combining blueberries with exercise has not shown any specific safety concerns in the studies reviewed. ^{1 3 4 6 7}

How does the blueberry treatment differ from other treatments for cognitive impairment?

The blueberry treatment is unique because it uses natural compounds found in blueberries, such as anthocyanins, which have antioxidant and anti-inflammatory effects that may improve memory and cognitive function. Unlike traditional medications, this treatment involves consuming blueberries, which are a natural food source, making it a novel dietary approach to potentially prevent or slow cognitive decline. ^{1 2 3 4 5}

Research Team

David C Nieman, DrPH

Principal Investigator

Appalachian State Univ

Eligibility Criteria

This trial is for healthy, non-smoking individuals aged 65-85 with mild cognitive decline. Participants must be physically inactive, willing to exercise (walking/stretching), avoid blueberries outside the study, and not use drugs affecting cognition. They can't have uncontrolled chronic conditions or a dementia diagnosis.

Inclusion Criteria

I am a healthy, non-smoking individual aged between 65 and 85.

I agree to only participate in this study and not join any others.

I can participate in a 12-week exercise program.

Exclusion Criteria

I am not taking any medication for cognition or that affects my thinking.

Allergy to blueberries

My heart, kidney, or metabolic condition has been stable for at least 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (phone call)

Pre-study Lab Testing

Orientation, consent, and pre-study cognitive and fitness testing

1 day

1 visit (in-person)

Treatment

Participants engage in 12 weeks of supervised physical activity sessions and consume blueberry or placebo supplements

12 weeks

60 sessions (in-person)

Follow-up

Participants are monitored for changes in cognitive function, gut microbiome, and other health metrics

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Blueberry
• Exercise

Trial Overview The NIH study tests if eating flavonoid-rich blueberries combined with regular moderate exercise improves cognitive function in older adults experiencing age-related cognitive changes. It explores how diet and physical activity might influence gut health and cognition.

Participant Groups

Group I: Blueberry + walking Experimental Treatment 2 Interventions

Blueberry intake combined with walking exercise.

Group II: Blueberry + stretching Experimental Treatment 2 Interventions

Blueberry intake combined with stretching exercise.

Group III: Placebo + stretching Active Control 2 Interventions

Placebo intake combined with stretching exercise.

Group IV: Placebo + walking Active Control 2 Interventions

Placebo intake combined with walking exercise.

Who Is Running the Clinical Trial?

Appalachian State University

Lead Sponsor

Trials

46

Recruited

2,600+

References

1. United States pubmed.ncbi.nlm.nih.gov

Blueberry supplementation improves memory in older adults. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Blueberry Supplementation in Midlife for Dementia Risk Reduction. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of the Effects of Blueberry on Cognitive Performance as We Age. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Blueberry phenolics are associated with cognitive enhancement in supplemented healthy older adults. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blinded, Placebo-Controlled Study to Compare the Safety and Efficacy of Low Dose Enhanced Wild Blueberry Powder and Wild Blueberry Extract (ThinkBlue™) in Maintenance of Episodic and Working Memory in Older Adults. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Blueberry Consumption and Exercise: Gap Analysis Using Evidence Mapping. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Blueberry Consumption Affects Serum Uric Acid Concentrations in Older Adults in a Sex-Specific Manner. [2020]