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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.
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.
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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 |
|---|---|---|
| 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. | Change between baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change between baseline and 12 week follow-up |
| Fecal Short Chain Fatty Acids (i.e., Butyrate) |
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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 |
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This is a sub-study of a larger, parent study (NCT 05735587) that aimed to recruit 40 individuals. All individuals that enrolled in the parent study (n=29) were offered to enroll in this sub study. Of the 29 individuals that enrolled in the parent study, 20 were enrolled in the sub-study. Of the 20 enrolled, 18 completed the sub-study.
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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 | 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. | Posted | Mean | Standard Deviation | scores on a scale | Change between baseline and 12 weeks |
|
Adverse events were collected throughout the entire study intervention period for each participant which was approximately 12 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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| 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. |
|
The relative abundance of short chain fatty acids (i.e., butyrate ) in feces will be measured using liquid chromatography mass spectrometry. |
| Percent 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 |
|
| OG001 | 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 | 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 | Posted | Mean | Standard Deviation | % Relative Abundance | Change between baseline and 12 week follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Percent change of relative abundance | Percent change between baseline and 12 week follow-up |
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| 0 |
| 10 |
| 0 |
| 10 |
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| 10 |
| 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 | 9 | 0 | 9 | 0 | 9 |
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