Depressive Symptoms
Conditions
Keywords
Anthocyanins, Fiber, Aging
Brief 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.
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.
Interventions
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.
OTHERPlacebo 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.
Sponsors
Hebrew SeniorLife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptom Severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abundance Microbes | Change between baseline and 12 week follow-up | 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 |
| Fecal Short Chain Fatty Acids (i.e., Butyrate) | Percent change between baseline and 12 week follow-up | The relative abundance of short chain fatty acids (i.e., butyrate ) in feces will be measured using liquid chromatography mass spectrometry. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Freeze-dried Blueberry Powder | Placebo Powder | Total |
|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 4 | 74 years STANDARD_DEVIATION 6 | 73 years STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 10 Participants | 19 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
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.
Time frame: Change between baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Depressive Symptom Severity | -5 scores on a scale | Standard Deviation 3 |
| Placebo Powder | Depressive Symptom Severity | -4 scores on a scale | Standard Deviation 4 |
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
Time frame: Change between baseline and 12 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Abundance Microbes | 1.28 % Relative Abundance | Standard Deviation 6.29 |
| Placebo Powder | Abundance Microbes | 1.63 % Relative Abundance | Standard Deviation 11.65 |
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.
Time frame: Percent change between baseline and 12 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze-dried Blueberry Powder | Fecal Short Chain Fatty Acids (i.e., Butyrate) | -2 Percent change of relative abundance | Standard Deviation 48 |
| Placebo Powder | Fecal Short Chain Fatty Acids (i.e., Butyrate) | 27 Percent change of relative abundance | Standard Deviation 60 |