Trial Outcomes & Findings for Blueberries, Inflammation, Motivation, and Physical Activity (NCT NCT05735587)
NCT ID: NCT05735587
Last Updated: 2025-07-30
Results Overview
Defined as change between an approximate 2-week median daily-step count prior to baseline and prior to 12 week follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Change between baseline and 12 week follow-up
Results posted on
2025-07-30
Participant Flow
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.
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
|
15
|
14
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blueberries, Inflammation, Motivation, and Physical Activity
Baseline characteristics by cohort
| Measure |
Freeze-dried Blueberry Powder
n=15 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=14 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=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 4 • n=5 Participants
|
73 years
STANDARD_DEVIATION 5 • n=7 Participants
|
72 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Height
|
1.6 meters
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.6 meters
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.6 meters
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Weight
|
81.4 kilograms
STANDARD_DEVIATION 23.0 • n=5 Participants
|
80.5 kilograms
STANDARD_DEVIATION 12.8 • n=7 Participants
|
81.0 kilograms
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Median Step Count
|
5916 steps per day
STANDARD_DEVIATION 1257 • n=5 Participants
|
6302 steps per day
STANDARD_DEVIATION 1325 • n=7 Participants
|
6103 steps per day
STANDARD_DEVIATION 1282 • n=5 Participants
|
|
Center for Epidemiological Scale for Depression (CESD)
|
8 scores on a scale
STANDARD_DEVIATION 4 • n=5 Participants
|
8 scores on a scale
STANDARD_DEVIATION 4 • n=7 Participants
|
8 scores on a scale
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Years of Education
13-15 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Years of Education
16-18 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Years of Education
19 or more years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and 12 week follow-upDefined as change between an approximate 2-week median daily-step count prior to baseline and prior to 12 week follow-up
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=12 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.
|
|---|---|---|
|
Change in Engagement in Physical Activity
|
318 steps per day
Standard Deviation 1778
|
346 steps per day
Standard Deviation 624
|
SECONDARY outcome
Timeframe: Through study completion, approximately 6 monthsParticipant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm)
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=15 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=14 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.
|
|---|---|---|
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Study Recruitment Feasibility
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Change between baseline and 12 week follow-upMotivation 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).
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=12 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.
|
|---|---|---|
|
Change in Motivation
|
4 score on a scale
Standard Deviation 18
|
0 score on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Change between Baseline and 12 week follow-up.C-reactive protein (mg/L) will be measured in blood collected from participants.
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=12 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.
|
|---|---|---|
|
Change in Inflammatory Marker - C-Reactive Protein
|
0.6 miligrams/liter
Standard Deviation 2.6
|
-1.6 miligrams/liter
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Change between Baseline and 12 week follow-upInterleukin-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.
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=12 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.
|
|---|---|---|
|
Change in Inflammatory Marker - Interleukin-6
|
-0.5 picograms/mililiter
Standard Deviation 1.2
|
-0.7 picograms/mililiter
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Change between Baseline and 12 week follow-upBrain derived neurotrophic (ng/mL) factor will be measured in blood collected from participants.
Outcome measures
| Measure |
Freeze-dried Blueberry Powder
n=12 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.
|
|---|---|---|
|
Change in Inflammatory Marker - Brain Derived Neurotrophic Factor
|
1.258 nanograms/mL
Standard Deviation 10.038
|
-1.226 nanograms/mL
Standard Deviation 12.116
|
Adverse Events
Freeze-dried Blueberry Powder
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Powder
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Freeze-dried Blueberry Powder
n=15 participants at risk
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=14 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
7.1%
1/14 • Number of events 1 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
|
Gastrointestinal disorders
Increased frequency of bowel movements
|
6.7%
1/15 • Number of events 1 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
7.1%
1/14 • Number of events 1 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
6.7%
1/15 • Number of events 1 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
0.00%
0/14 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
|
Product Issues
Unpleasant taste and/or experience while taking study powder
|
0.00%
0/15 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
14.3%
2/14 • Number of events 2 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
|
Gastrointestinal disorders
Bloating
|
6.7%
1/15 • Number of events 1 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
7.1%
1/14 • Number of events 1 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
|
Cardiac disorders
High Blood Pressure
|
0.00%
0/15 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
7.1%
1/14 • Number of events 1 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
0.00%
0/14 • Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place