Blueberry Supplements 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: Cognitive impairment, Diabetes, Psychotic disorders, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if powdered blueberries can help older adults with depression feel better and become more active by reducing inflammation.

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. Participants must spend a lot of time sitting and not have cognitive impairments, diabetes, substance abuse issues, severe psychiatric disorders, inflammatory bowel conditions, allergies to the products used in the study, or be taking certain medications like antibiotics or antidepressants.

Inclusion Criteria

I have mild to moderate depression.

I am 65 years old or older.

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

Exclusion Criteria

Self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders, or per discretion of the PI

I walk more than 7,500 steps a day, or my doctor agrees I'm active enough.

Cognitive impairment (defined as Montreal Cognitive Assessment, MoCA <22 points)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Washout

Participants avoid consumption of foods high in fiber and anthocyanins and wear an activity monitor

2 weeks

1 visit (in-person)

Treatment

Participants consume either freeze-dried blueberry powder or placebo powder daily, with assessments at baseline, 4, 6, 8, and 12 weeks

12 weeks

5 visits (in-person)

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 daily freeze-dried blueberry powder can help reduce inflammation and improve motivation to be active compared to a placebo powder. It's designed for older adults who don't exercise much and feel down sometimes.

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+