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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dose Freeze-dried Blueberry Powder | Active Comparator | Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days. |
|
| Higher Dose Freeze-dried Blueberry Powder | Experimental | Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried Blueberry Powder | Other | Three day consumption of two doses of freeze-dried blueberry powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 3 of intervention |
| Inflammatory Biomarker C-reactive Protein | Change in serum C-reactive Protein | Baseline and Day 3 of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Biomarker Tumor Necrosis Factor Alpha | Change in tumor necrosis factor alpha | Baseline and Day 3 of intervention |
| Inflammatory Biomarker Interleukin 6 | Change in interleukin 6 |
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Inclusion Criteria:
Exclusion Criteria*:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebrew Rehabilitation Center | Roslindale | Massachusetts | 02131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Freeze-dried Blueberry Powder (Standard Dose Then Higher Dose) | Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days and then consumption of 48 g of freeze dried blueberry powder for 3 consecutive days, separated by a washout. |
| FG001 | Freeze-dried Blueberry Powder (Higher Dose Then Standard Dose) | Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days and then consumption of 24 g of freeze dried blueberry powder for 3 consecutive days, separated by a washout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Freeze-dried Blueberry Powder (Standard Dose Then Higher Dose) | Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days and then consumption of 48 g of freeze dried blueberry powder for 3 consecutive days, separated by a washout. |
| BG001 | Freeze-dried Blueberry Powder (Higher Dose Then Standard Dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Unitless | Baseline and Day 3 of intervention |
|
From enrollment until end of study visits, ~ 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Dose of Freeze-dried Blueberry Powder | Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days |
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This data is used as hypothesis generating, and is a very small sample size. Interpret the results with caution.
The data for interferon-gamma is delayed due to the assay kit being back-ordered. We hope to submit these results by January 2026.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Millar | Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School | 6179715531 | courtneymillar@hsl.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2024 | Nov 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Baseline and Day 3 of intervention |
| Inflammatory Biomarker Interferon Gamma | Change in serum interferon gamma | Baseline and Day 3 of intervention |
Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days and then consumption of 24 g of freeze dried blueberry powder for 3 consecutive days, separated by a washout. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Depressive Symptom Severity | Center for Epidemiological Studies Depression Scale - Revised (CESD-R). Scores range from 0-60 with higher points indicating more severe symptoms of depression. | Mean | Standard Deviation | points |
|
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| Primary | Inflammatory Biomarker C-reactive Protein | Change in serum C-reactive Protein | Posted | Mean | Standard Deviation | nanograms/mL | Baseline and Day 3 of intervention |
|
|
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| Secondary | Inflammatory Biomarker Tumor Necrosis Factor Alpha | Change in tumor necrosis factor alpha | Posted | Mean | Standard Deviation | picograms/mL | Baseline and Day 3 of intervention |
|
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| Secondary | Inflammatory Biomarker Interleukin 6 | Change in interleukin 6 | Posted | Mean | Standard Deviation | picograms/mL | Baseline and Day 3 of intervention |
|
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| Secondary | Inflammatory Biomarker Interferon Gamma | Change in serum interferon gamma | Not Posted | Jan 2026 | Baseline and Day 3 of intervention | Participants |
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Higher Dose of Freeze-dried Blueberry Powder | Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days | 0 | 6 | 0 | 6 | 0 | 6 |
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