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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily consumption of freeze-dried blueberry powder can improve gut health and reduce depression symptoms. Participants will randomly consume either the freeze-dried blueberry powder or a placebo powder for 12 weeks. The study seeks older adults who spend much time sitting and have mild to moderate depressive symptoms.

As an unphased trial, this study allows participants to contribute to valuable research on natural interventions for mental and gut health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that most people can handle freeze-dried blueberry powder without problems. Some studies found that drinks made with freeze-dried blueberries might cause minor issues like constipation, diarrhea, nausea, or vomiting in some individuals. However, reliable information about these effects in large groups remains limited.

The trial is in the "not applicable" phase, indicating that detailed safety information might not yet be available. Since blueberries are a common food, many people consume them without major issues. Always consult a healthcare provider if there are concerns or existing health conditions before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Freeze-dried blueberry powder is unique because it's a natural, food-based approach to managing depression, unlike typical treatments such as antidepressants and therapy. Researchers are excited about it because blueberries are rich in anthocyanins, which have antioxidant and anti-inflammatory properties that might improve mood. This treatment offers a potentially safer and more accessible option with fewer side effects compared to conventional medications.

What evidence suggests that freeze-dried blueberry powder might be an effective treatment for depression?

This trial will compare the effects of Freeze-dried Blueberry Powder with a Placebo Powder on depression. Studies have shown that blueberries might improve mood and reduce symptoms of depression. In one study, people who ate at least 67 grams of berries daily were 52% less likely to feel depressed compared to those who didn't eat berries. Another study found that just one serving of blueberries could boost mood in children and young adults with mild depression. Blueberries are rich in natural compounds called flavonoids, which may help lift mood. Research also suggests that eating blueberries every day for four weeks can improve mood in teens. These studies indicate that blueberries might effectively reduce depressive symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Courtney Millar, PhD

Principal Investigator

Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

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We investigated the effects of 4 weeks, daily WBB supplementation (containing about 253 mg anthocyanins) on transient and chronic mood in adolescents.

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Drinks made with freeze-dried blueberries might cause constipation, diarrhea, nausea, or vomiting in some people. There isn't enough reliable information to ...

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Blueberry Powder for Depression in Aging

The provided research does not contain specific safety data for blueberry powder or its variants like freeze-dried blueberry powder, bilberry powder, or wild ...

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We propose a study intervention protocol, which aims to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberries.

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The acute and chronic effects of a freeze-dried wild blueberry ...

The cognitive, reading behaviour, and mood, effects of a freeze-dried WBB powder beverage (253 mg anthocyanins) were investigated in four placebo-controlled, ...