Depressive SymptomsNCT05817383
Berries, Bugs, and the Blues
A study testing Freeze-dried Blueberry Powder in people with Depressive Symptoms, run by Hebrew SeniorLife at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Freeze-dried Blueberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2023to 16 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
Official title: Blueberries, Gut Microbiota, and Metabolites in Depressed Older Adults - A Pilot Study
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.
Read the detailed 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.
- Conditions
- Depressive Symptoms
- Being tested
- Freeze-dried Blueberry Powder, Placebo Powder
- Keywords
- Anthocyanins, Fiber, Aging
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried Blueberry PowderOther
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 PowderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Freeze-dried Blueberry Powder | Experimental | Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks. Receives: Other: Freeze-dried Blueberry Powder |
| Placebo Powder | Placebo comparator | 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. Receives: Other: Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Severity
Severity of depressive symptoms will be measured before and after the intervention with the Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scores range from 0 to 60 points, with higher scores indicating more sever depressive symptoms.
Measured: Change between baseline and 12 weeks
Secondary outcomes (2)
Abundance Microbes
The abundance of the top 20 most prevalent microbes in our that produce short chain fatty acids (e.g., Bifidobacteria, Eubacterium, and Clostridium) will be evaluated by whole genome sequencing
Measured: Change between baseline and 12 week follow-up
Fecal Short Chain Fatty Acids (i.e., Butyrate)
The relative abundance of short chain fatty acids (i.e., butyrate ) in feces will be measured using liquid chromatography mass spectrometry.
Measured: Percent change between baseline and 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start5 Apr 2023
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Millar, Hebrew SeniorLife
- Investigators
- Courtney Millar, PhD, Principal investigator, Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817383
- Sponsor's protocol ID
- Pro00068528
- Status last verified
- Aug 2025
- First submitted
- 5 Apr 2023
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blueberries, Gut Microbiota, and Metabolites in Depressed Older Adults - A Pilot Study
- ClinicalTrials.gov ID
- NCT05817383
- Acronym / sponsor ID
- Pro00068528
- Conditions
- Depressive Symptoms
- Keywords
- Anthocyanins, Fiber, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze-dried Blueberry Powder | Experimental | Other: Freeze-dried Blueberry PowderRandomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks. |
| Placebo Powder | Placebo comparator | Other: Placebo PowderRandomized participants will be asked to consume 48 grams of a nutritionally matched placebo powder devoid of fiber and anthocyanins each day for 12 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freeze-dried Blueberry PowderParticipants 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 | Freeze-dried Blueberry Powder |
| Placebo PowderParticipants 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. | Other | Placebo Powder |
Primary outcome
Depressive Symptom Severity
Time frame: Change between baseline and 12 weeks
Severity of depressive symptoms will be measured before and after the intervention with the Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scores range from 0 to 60 points, with higher scores indicating more sever depressive symptoms.
2 secondary outcomes
Abundance Microbes
Time frame: Change between baseline and 12 week follow-up
Fecal Short Chain Fatty Acids (i.e., Butyrate)
Time frame: Percent change between baseline and 12 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Millar, PhD principal investigator
Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-dried Blueberry Powder in people with Depressive Symptoms, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptom Severity (time frame: Change between baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.