Trial Outcomes & Findings for Berries, Bugs, and the Blues (NCT NCT05817383)
NCT ID: NCT05817383
Last Updated: 2025-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Change between baseline and 12 weeks
Results posted on
2025-08-22
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Berries, Bugs, and the Blues
Baseline characteristics by cohort
| Measure |
Freeze-dried Blueberry Powder
n=10 Participants
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.
|
Placebo Powder
n=10 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 4 • n=99 Participants
|
74 years
STANDARD_DEVIATION 6 • n=107 Participants
|
73 years
STANDARD_DEVIATION 5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and 12 weeksSeverity 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.
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=10 Participants
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.
|
Placebo Powder
n=8 Participants
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.
|
|---|---|---|
|
Depressive Symptom Severity
|
-5 scores on a scale
Standard Deviation 3
|
-4 scores on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Change between baseline and 12 week follow-upThe 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
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=10 Participants
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.
|
Placebo Powder
n=8 Participants
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.
|
|---|---|---|
|
Abundance Microbes
|
1.28 % Relative Abundance
Standard Deviation 6.29
|
1.63 % Relative Abundance
Standard Deviation 11.65
|
SECONDARY outcome
Timeframe: Percent change between baseline and 12 week follow-upThe relative abundance of short chain fatty acids (i.e., butyrate ) in feces will be measured using liquid chromatography mass spectrometry.
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=9 Participants
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.
|
Placebo Powder
n=8 Participants
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.
|
|---|---|---|
|
Fecal Short Chain Fatty Acids (i.e., Butyrate)
|
-2 Percent change of relative abundance
Standard Deviation 48
|
27 Percent change of relative abundance
Standard Deviation 60
|
Adverse Events
Freeze-dried Blueberry Powder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Powder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place