Blueberry Powder for Depression

Overseen By Katie Baldyga, BA

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Hebrew SeniorLife

Must not be taking: Antibiotics, Pro-biotics, Antidepressants, others

Disqualifiers: Diabetes, Bipolar, Schizophrenia, others

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to investigate the impact of daily freeze-dried blueberry powder consumption on the gut microbiota, fecal short chain fatty acids, and depressive symptom severity in 40older, sedentary adults with depressive symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants with unstable antidepressant use (recent changes in medication) may be excluded. It's best to discuss your specific medications with the trial coordinators.

Is blueberry powder safe for human consumption?

Research on blueberries, including freeze-dried blueberry powder, shows no significant safety concerns in humans. Studies have focused on their effects on cardiovascular health and cancer prevention, but no adverse effects were reported. ^{1 2 3 4 5}

How is the blueberry powder treatment for depression different from other treatments?

The blueberry powder treatment is unique because it uses natural compounds found in blueberries, which have antioxidant and anti-inflammatory properties that may help improve brain function and reduce depression symptoms. Unlike traditional antidepressants, this treatment focuses on enhancing neuroplasticity (the brain's ability to adapt and change) and reducing neuroinflammation, offering a potentially safer and more natural alternative. ^{1 6 7 8 9}

Research Team

Courtney Millar, PhD

Principal Investigator

Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools

Eligibility Criteria

This trial is for sedentary adults aged 65 or older with mild depressive symptoms who sit for more than 8 hours a day. They must not be very active, have cognitive impairments, diabetes, recent probiotic or antibiotic use, substance abuse issues, severe psychiatric conditions like major depression or psychosis, nor can they be allergic to the study products.

Inclusion Criteria

I experience mild to moderate depression.

Self-reporting ≥ 8 hours of sitting per/day (e.g., sedentary behavior)

I am 65 years old or older.

Exclusion Criteria

Presence of current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener)

Unwilling to follow the study protocol

Presence of current psychosis (assessed via the Psychosis and Hallucinations Questionnaire, PHQ>12 points)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments for depressive symptom severity and provide a fecal sample for gut microbiota and short chain fatty acid measurement

1 week

1 visit (in-person)

Treatment

Participants consume either freeze-dried blueberry powder or placebo powder daily for 12 weeks

12 weeks

3 visits (in-person) at 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Freeze-dried Blueberry Powder
• Placebo Powder

Trial Overview The study tests if consuming freeze-dried blueberry powder daily affects gut health and eases depressive symptoms compared to a placebo in inactive older adults. Participants will randomly receive either the blueberry powder or a placebo and their mood and gut health will be monitored.

Participant Groups

Group I: Freeze-dried Blueberry Powder Experimental Treatment 1 Intervention

Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks.

Group II: Placebo Powder Placebo Group 1 Intervention

Randomized participants will be asked to consume 48 grams of a nutritionally matched placebo powder devoid of fiber and anthocyanins each day for 12 weeks.

Freeze-dried Blueberry Powder is already approved in United States, European Union for the following indications:

Approved in United States as Freeze-dried Blueberry Powder for:

• General health and wellness
• Antioxidant supplementation

Approved in European Union as Bilberry Powder for:

• General health and wellness
• Antioxidant supplementation

Who Is Running the Clinical Trial?

Hebrew SeniorLife

Lead Sponsor

Trials

52

Recruited

273,000+

Findings from Research

In a study involving 37 young adults, both whole blueberries and freeze-dried blueberry powder did not show significant differences in improving cardiovascular health compared to a control group, indicating that the form of blueberry may not matter for cardiovascular benefits.

However, both blueberry treatments improved plasma nitrite levels significantly compared to baseline, suggesting a potential positive effect on vascular function, even though other cardiovascular risk factors like blood pressure and cholesterol levels did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Blueberry Consumption on Cardiovascular Health in Healthy Adults: A Cross-Over Randomised Controlled Trial. Wang, Y., Gallegos, JL., Haskell-Ramsay, C., et al.[2022]

Berries, particularly in freeze-dried powder form, contain powerful chemopreventive agents like anthocyanins and ellagitannins, which show promise in preventing cancer based on laboratory research.

The commentary outlines a stepwise scheme for developing food-based cancer prevention strategies, highlighting preclinical assessments and preliminary clinical trial results in areas such as the oral cavity, esophagus, and colon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foodstuffs for preventing cancer: the preclinical and clinical development of berries. Stoner, GD.[2021]

The study found that the stems of wild bilberry (Vaccinium myrtillus) contain significantly higher levels of procyanidin type A trimers, a known antidiabetic compound, compared to the leaves, with concentrations up to 100 times greater.

Geographical and seasonal variations can greatly affect the active compound levels in bilberry plants, suggesting that the stems of V. myrtillus should be prioritized for future research on diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability of procyanidin type A- and -B trimers content in aerial parts of some Vaccinium species and cultivars. Toomik, P., Püssa, T., Raal, A.[2014]

In a study involving male Swiss mice, blueberry extract (200 mg/kg) significantly reduced depressive-like behavior, similar to the effects of fluoxetine, without affecting locomotor activity, suggesting its potential as a natural antidepressant.

Blueberry extract also demonstrated neuroprotective effects by improving Na+/K+-ATPase activity and reducing neuroinflammatory markers in the brain, indicating its ability to counteract neurochemical changes associated with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blueberry Extract Modulates Brain Enzymes Activities and Reduces Neuroinflammation: Promising Effect on Lipopolysaccharide-Induced Depressive-Like Behavior. Spohr, L., de Aguiar, MSS., Bona, NP., et al.[2023]

Blueberry extract demonstrated antidepressant-like effects in mice, effectively protecting against depressive-like behavior induced by lipopolysaccharide (LPS), similar to the effects of fluoxetine, without affecting locomotor activity.

The extract also restored oxidative stress markers and reduced neuroinflammation by modulating tumor necrosis factor-alpha (TNF-α) levels, indicating its potential as a neuroprotective agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blueberry extract as a potential pharmacological tool for preventing depressive-like behavior and neurochemical dysfunctions in mice exposed to lipopolysaccharide. Spohr, L., Luduvico, KP., Soares, MSP., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Blueberry Consumption on Cardiovascular Health in Healthy Adults: A Cross-Over Randomised Controlled Trial. [2022]

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

Foodstuffs for preventing cancer: the preclinical and clinical development of berries. [2021]

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

Quality Assessment of Bilberry Fruits (Vaccinium myrtillus) and Bilberry-Containing Dietary Supplements. [2021]

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

Blueberry polyphenol-protein food ingredients: The impact of spray drying on the in vitro antioxidant activity, anti-inflammatory markers, glucose metabolism and fibroblast migration. [2022]

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

Variability of procyanidin type A- and -B trimers content in aerial parts of some Vaccinium species and cultivars. [2014]

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

Blueberry Extract Modulates Brain Enzymes Activities and Reduces Neuroinflammation: Promising Effect on Lipopolysaccharide-Induced Depressive-Like Behavior. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Blueberry extract as a potential pharmacological tool for preventing depressive-like behavior and neurochemical dysfunctions in mice exposed to lipopolysaccharide. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Blueberry Phenolics Reduce Gastrointestinal Infection of Patients with Cerebral Venous Thrombosis by Improving Depressant-Induced Autoimmune Disorder via miR-155-Mediated Brain-Derived Neurotrophic Factor. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Hydroalcoholic Extract of Rabbiteye Blueberry (Vaccinium ashei) Leaves Mitigates Unpredictable Chronic Mild Stress Model Inducing Depressive-Like Behavior in Rats. [2023]