Depressive SymptomsNCT05937165
ABSORB (Amount of Blueberries So Older Adults Reap Benefits)
A study testing Freeze-dried Blueberry Powder in people with Depressive Symptoms and Aging, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
This randomized, cross-over, pilot study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Aging
- What is being tested?
- Freeze-dried Blueberry Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 25 Nov 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women aged 65 years and older
- Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points)
Who cannot join
- Unwilling to follow the study protocol
- Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring <19)
- Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders
- Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease
- Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions
- Self-reporting history of type 1 or type 2 diabetes
Show all 14Show fewer
- Self-reporting any history of substance or alcohol use disorder
- Allergy to blueberries
- Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs
- Are excessive tea or coffee consumers (e.g., >3 cups/day)
- Recent and consistent use of antibiotics
- Currently taking or advised during the intervention to take anti-depressants
- Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener
- All deviations must be approved by the study sponsor
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
Official title: Acute Bioavailability of Berry Flavonoids and Impact on Inflammatory Biomarkers in Older Adults With Minor Depressive Symptoms: A Pilot Study
This randomized, cross-over, pilot study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms.
Read the detailed description
Blueberries are a rich source of anti-oxidants and dietary fiber, and are recommended to consume as a part of a healthy diet. Regular consumption of blueberries as a source of dietary antioxidants may be an effective way to lower inflammation in older adults, who commonly have higher levels of inflammatory markers. However, older adults typically have a decreased efficiency of nutrient absorption and may need a higher dose of blueberries to absorb enough of the flavonoids needed to reap their benefits on inflammation. Thus, it is important for preliminary studies to pre-determine an appropriate dose of blueberry flavonoids specifically for older adults. This study aims to evaluated the preliminary impact of freeze-dried blueberry powder consumption on flavonoid bioavailability and inflammatory biomarkers in older adults. This will be an individual-level, unblinded, randomized, cross over pilot study in 5 older adults with minor levels of depressive symptoms. Eligible participants will collect a 24 hour urine sample, and then come in for the baseline assessments and provide a blood sample. Next they will be randomized to consume either the higher dose (48 g/day, equivalent ~ 2 cups of fresh blueberries) or the lower dose (24 g/day, equivalent ~1 cup of fresh blueberries) for 3 days. After 3 days they will begin collecting a 24 hour urine sample, and come in to repeat the baseline assessments and provide a blood sample. After a two week wash out period, participants will repeat the same baseline and follow-up assessments while consuming the other powder.
- Conditions
- Depressive Symptoms, Aging
- Being tested
- Freeze-dried Blueberry Powder
- 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
Three day consumption of two doses of freeze-dried blueberry powder
| Study group | Role | What they receive |
|---|---|---|
| Standard Dose Freeze-dried Blueberry Powder | Active comparator | Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days. Receives: Other: Freeze-dried Blueberry Powder |
| Higher Dose Freeze-dried Blueberry Powder | Experimental | Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days. Receives: Other: Freeze-dried Blueberry Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Flavonoid Biomarkers
Change in total flavonoid metabolites found in the urine. The values for the metabolites represent the relative abundance of each metabolite, rather than absolute quantification, with higher values reflecting higher levels of total flavonoid metabolites in the urine.
Measured: Baseline and Day 3 of intervention
Inflammatory Biomarker C-reactive Protein
Change in serum C-reactive Protein
Measured: Baseline and Day 3 of intervention
Secondary outcomes (3)
Inflammatory Biomarker Tumor Necrosis Factor Alpha
Change in tumor necrosis factor alpha
Measured: Baseline and Day 3 of intervention
Inflammatory Biomarker Interleukin 6
Change in interleukin 6
Measured: Baseline and Day 3 of intervention
Inflammatory Biomarker Interferon Gamma
Change in serum interferon gamma
Measured: Baseline and Day 3 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start31 Oct 2023
- Primary completion25 Nov 2024
- Study completion25 Nov 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937165
- Sponsor's protocol ID
- Pro00069826
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2023
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Bioavailability of Berry Flavonoids and Impact on Inflammatory Biomarkers in Older Adults With Minor Depressive Symptoms: A Pilot Study
- ClinicalTrials.gov ID
- NCT05937165
- Acronym / sponsor ID
- Pro00069826
- Conditions
- Depressive Symptoms, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Posted 15 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, cross-over, pilot study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms.
Detailed description
Blueberries are a rich source of anti-oxidants and dietary fiber, and are recommended to consume as a part of a healthy diet. Regular consumption of blueberries as a source of dietary antioxidants may be an effective way to lower inflammation in older adults, who commonly have higher levels of inflammatory markers. However, older adults typically have a decreased efficiency of nutrient absorption and may need a higher dose of blueberries to absorb enough of the flavonoids needed to reap their benefits on inflammation. Thus, it is important for preliminary studies to pre-determine an appropriate dose of blueberry flavonoids specifically for older adults. This study aims to evaluated the preliminary impact of freeze-dried blueberry powder consumption on flavonoid bioavailability and inflammatory biomarkers in older adults. This will be an individual-level, unblinded, randomized, cross over pilot study in 5 older adults with minor levels of depressive symptoms. Eligible participants will collect a 24 hour urine sample, and then come in for the baseline assessments and provide a blood sample. Next they will be randomized to consume either the higher dose (48 g/day, equivalent ~ 2 cups of fresh blueberries) or the lower dose (24 g/day, equivalent ~1 cup of fresh blueberries) for 3 days. After 3 days they will begin collecting a 24 hour urine sample, and come in to repeat the baseline assessments and provide a blood sample. After a two week wash out period, participants will repeat the same baseline and follow-up assessments while consuming the other powder.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dose Freeze-dried Blueberry Powder | Active comparator | Other: Freeze-dried Blueberry PowderConsumption of 24 g of freeze dried blueberry powder for 3 consecutive days. |
| Higher Dose Freeze-dried Blueberry Powder | Experimental | Other: Freeze-dried Blueberry PowderConsumption of 48 g of freeze dried blueberry powder for 3 consecutive days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women aged 65 years and older
- Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points)
Key exclusion criteria (14 listed)
- Unwilling to follow the study protocol
- Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring <19)
- Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders
- Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease
- Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions
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 PowderThree day consumption of two doses of freeze-dried blueberry powder | Other | Higher Dose Freeze-dried Blueberry Powder, Standard Dose Freeze-dried Blueberry Powder |
Primary outcome
Urinary Flavonoid Biomarkers
Time frame: Baseline and Day 3 of intervention
Change in total flavonoid metabolites found in the urine. The values for the metabolites represent the relative abundance of each metabolite, rather than absolute quantification, with higher values reflecting higher levels of total flavonoid metabolites in the urine.
Inflammatory Biomarker C-reactive Protein
Time frame: Baseline and Day 3 of intervention
Change in serum C-reactive Protein
3 secondary outcomes
Inflammatory Biomarker Tumor Necrosis Factor Alpha
Time frame: Baseline and Day 3 of intervention
Inflammatory Biomarker Interleukin 6
Time frame: Baseline and Day 3 of intervention
Inflammatory Biomarker Interferon Gamma
Time frame: Baseline and Day 3 of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Depressive Symptoms
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Aging, 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 2 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 15 Dec 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. 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 15 Dec 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?
Urinary Flavonoid Biomarkers (time frame: Baseline and Day 3 of intervention). The study lists 2 primary outcomes in all. 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 15 Dec 2025.