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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05817383




Registration number
NCT05817383
Ethics application status
Date submitted
5/04/2023
Date registered
18/04/2023

Titles & IDs
Public title
Berries, Bugs, and the Blues
Scientific title
Blueberries, Gut Microbiota, and Metabolites in Depressed Older Adults - A Pilot Study
Secondary ID [1] 0 0
Pro00068528
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Symptoms 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Freeze-dried Blueberry Powder
Other interventions - Placebo Powder

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

Placebo comparator: Placebo Powder - 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.


Other interventions: 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.

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depressive Symptom Severity
Timepoint [1] 0 0
Up to 12 weeks
Secondary outcome [1] 0 0
Abundance microbes
Timepoint [1] 0 0
After 12 weeks
Secondary outcome [2] 0 0
Fecal short chain fatty acids
Timepoint [2] 0 0
After 12 weeks

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Hebrew SeniorLife
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Courtney Millar, PhD
Address 0 0
Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05817383