Berries, Bugs, and the Blues

Depressive Symptoms Clinical Trial

Official title:

Blueberries, Gut Microbiota, and Metabolites in Depressed Older Adults - A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05817383
• Other study ID #: Pro00068528
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Hebrew SeniorLife
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is an ancillary project to a currently funded randomized, placebo-controlled 12-week intervention in older, sedentary adults with depressive symptoms (IRB# Pro00064749). This specific project proposes distinct aims to the trial by gathering preliminary data on the synergistic impact of dietary fiber and anthocyanins (via freeze-dried blueberry powder) on the gut-microbiota, gut-derived metabolites, and depressive symptoms in older adults.

Participants will then be randomized to consume either 48 g of freeze-dried blueberry powder (~600 mg of anthocyanins and ~8 g of fiber) or 48 g of a nutritionally matched placebo powder (devoid of anthocyanins and fiber) each day for a total of 12 weeks.

At baseline, participants will be undergo assessments for depressive symptom severity and provide a fecal sample for gut microbiota and short chain fatty acid measurement. After 4, 8, and 12 weeks of consuming the powder there will be study visits that assess depressive symptom severity. Additionally, a final fecal sample will be taken after 12 weeks of the intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged =65 years

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

• Depressive symptoms (defined as =4 and <16 points on the center for epidemiological studies depression-scale

Exclusion Criteria:

• Unwilling to follow the study protocol

• A median daily step count >7,500 steps per day (as measured by the ActiGraph), or per discretion of the PI

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

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

• Self-reporting type 1 or type 2 diabetes

• Allergic to intervention or control products

• Recent use (within the last 3 months) of antibiotics, or per discretion of the PI

• Recent use (within the last 3 months) of pro-biotics, or per discretion of the PI

• Current substance use disorder (Drug Abuse Screening Test, DAST-10>2 points)

• Current alcohol use disorder (Alcohol Use Disorders Identification Test - Consumption, AUDIT-C=4 points)

• Unstable anti-depressant use (e.g., change in medication within last 3-6 months), or per discretion of the PI

• Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener)

• Current psychosis (via the Psychosis and Hallucinations Questionnaire, PHQ>12 points)

• Manic symptoms (assessed by the Mood Disorder Questionnaire, MDQ >5 points)

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Other:
• Freeze-dried Blueberry Powder
Participants will be asked to consume 48 grams of freeze-dried blueberry powder (~ equivalent to 2 cups of fresh blueberries) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.
• Placebo Powder
Participants will be asked to consume 48 grams of a nutritionally matched placebo powder (that does not contain fiber or anthocyanins) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.

Locations

Country	Name	City	State
United States	Hebrew Rehabilitation Center	Roslindale	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew SeniorLife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive Symptom Severity	Severity of depressive symptoms will be measured each week with the Center for Epidemiological Studies Depression Scale (CES-D). Scores range from 0 to 60 points, with higher scores indicating more sever depressive symptoms.	Up to 12 weeks
Secondary	Abundance microbes	The abundance of microbes that produce short chain fatty acids(e.g., Bifidobacteria, Eubacterium, and Clostridium) will be evaluated by whole genome sequencing	After 12 weeks
Secondary	Fecal short chain fatty acids	The concentration of short chain fatty acids in feces will be measured using gas chromatography mass spectrometry.	After 12 weeks