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The purpose of this study is to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberry to modulate inflammation-driven lack of motivation in 40 sedentary, older adults with depressive symptoms.
The investigators will conduct a 14 week, single-site, randomized, double-blind, parallel pilot study in 40 sedentary, older adults with depressive symptoms. Participants will first enter a 2-week washout period where they will avoid consumption of foods high in fiber and anthocyanins (e.g., blueberries) and will also be wearing an activity monitor. 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 mood/well-being, relevant symptoms, motivation to engage in physical activity, and provide a blood sample for the evaluation of inflammatory biomarkers. For the entire duration of the study, participants will continue to wear the activity monitor. After 4, 6, 8 and 12 weeks of consuming the powder there will be study visits that assess mood/well-being, relevant symptoms, motivation to engage in physical activity and compliance with the intervention. Additionally, a blood sample for the evaluation of inflammatory makers will be taken after 6 and 12 weeks of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Experimental | Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried Blueberry Powder | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Engagement in Physical Activity | Defined as change between an approximate 2-week median daily-step count prior to baseline and prior to 12 week follow-up | Change between baseline and 12 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Study Recruitment Feasibility | Participant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm) | Through study completion, approximately 6 months |
| Change in Motivation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Millar, PhD | Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebrew Rehabilitation Center | Roslindale | Massachusetts | 02131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40442715 | Derived | Millar CL, Wolfe A, Baldyga K, Dufour AB, Lipsitz LA. Berries and Steps: a protocol of a randomized, placebo-controlled pilot study testing freeze-dried blueberry powder in sedentary older adults with mild depressive symptoms. Nutr J. 2025 May 29;24(1):87. doi: 10.1186/s12937-025-01154-0. |
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Our original goal was to recruit 40 individuals. However, recruitment was challenging and we ultimately enrolled 33 individuals. Of the 33 individuals that signed the consent form, there were 4 individuals who either did not follow the study protocol (n=2) or were lost to follow-p (n=2) before completing the baseline visit/randomization. Thus, a total of 29 individuals were enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Freeze-dried Blueberry Powder | Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Freeze-dried Blueberry Powder | Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks. 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. |
| 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 | Change in Engagement in Physical Activity | Defined as change between an approximate 2-week median daily-step count prior to baseline and prior to 12 week follow-up | Posted | Mean | Standard Deviation | steps per day | Change between baseline and 12 week follow-up |
|
Adverse events were captured throughout the study duration of each participant, which was approximately 14 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 | Freeze-dried Blueberry Powder | Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Courtney Millar | Hebrew Rehabilitation Center | 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 | Feb 1, 2024 | Jul 29, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Placebo Powder | Other | 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. |
|
Motivation to engage in physical activity will be assessed via self-report questionnaire, Motives for Physical Activities Measure-Revised (range 0-30 points, with higher scores indicating higher levels of motivation).
| Change between baseline and 12 week follow-up |
| Change in Inflammatory Marker - C-Reactive Protein | C-reactive protein (mg/L) will be measured in blood collected from participants. | Change between Baseline and 12 week follow-up. |
| Change in Inflammatory Marker - Interleukin-6 | Interleukin-6 (pg/mL) will be measured in blood collected from participants. If values were above the standard curve in the ELISA kit (n= 2 samples), then the highest standard concentration was used as the value. | Change between Baseline and 12 week follow-up |
| Change in Inflammatory Marker - Brain Derived Neurotrophic Factor | Brain derived neurotrophic (ng/mL) factor will be measured in blood collected from participants. | Change between Baseline and 12 week follow-up |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | meters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Median Step Count | The median daily step count over approximately 14 days just before their baseline visit was estimated for each participant. For days that the device registered was less than 300 steps were considered missing. | Mean | Standard Deviation | steps per day |
|
| Center for Epidemiological Scale for Depression (CESD) | A validated, self report questionnaire that measures of depressive symptom severity, with higher scores indicating more severe symptoms. Scores range from 0-60 points. | Mean | Standard Deviation | scores on a scale |
|
| Years of Education | Count of Participants | Participants |
|
| 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. 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. |
|
|
| Secondary | Study Recruitment Feasibility | Participant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm) | Posted | Count of Participants | Participants | Through study completion, approximately 6 months |
|
|
|
| Secondary | Change in Motivation | Motivation to engage in physical activity will be assessed via self-report questionnaire, Motives for Physical Activities Measure-Revised (range 0-30 points, with higher scores indicating higher levels of motivation). | Posted | Mean | Standard Deviation | score on a scale | Change between baseline and 12 week follow-up |
|
|
|
| Secondary | Change in Inflammatory Marker - C-Reactive Protein | C-reactive protein (mg/L) will be measured in blood collected from participants. | Posted | Mean | Standard Deviation | miligrams/liter | Change between Baseline and 12 week follow-up. |
|
|
|
| Secondary | Change in Inflammatory Marker - Interleukin-6 | Interleukin-6 (pg/mL) will be measured in blood collected from participants. If values were above the standard curve in the ELISA kit (n= 2 samples), then the highest standard concentration was used as the value. | Posted | Mean | Standard Deviation | picograms/mililiter | Change between Baseline and 12 week follow-up |
|
|
|
| Secondary | Change in Inflammatory Marker - Brain Derived Neurotrophic Factor | Brain derived neurotrophic (ng/mL) factor will be measured in blood collected from participants. | Posted | Mean | Standard Deviation | nanograms/mL | Change between Baseline and 12 week follow-up |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | 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. 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. | 0 | 14 | 0 | 14 | 4 | 14 |
| Increased frequency of bowel movements | Gastrointestinal disorders | Systematic Assessment |
|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Unpleasant taste and/or experience while taking study powder | Product Issues | Systematic Assessment | Described as "a lingering blueberry taste" or as an "irritated esophagus" |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| High Blood Pressure | Cardiac disorders | Systematic Assessment | This occurred at baseline. Participant was aware this issue was present prior to our study and had been trying to get an appointment with their doctor. Study staff contacted their doctor and the participant was received treatment. |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
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