Trial Outcomes & Findings for Blueberry Consumption and Type 2 Diabetes (NCT NCT02972996)
NCT ID: NCT02972996
Last Updated: 2022-04-19
Results Overview
Systolic blood pressure and diastolic blood pressure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-04-19
Participant Flow
Participant milestones
| Measure |
Blueberry
Blueberry: 22 g freeze-dried whole blueberry powder
|
Placebo
Placebo: 22 g placebo blueberry powder
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blueberry Consumption and Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Blueberry
n=26 Participants
Blueberry: 22 g freeze-dried whole blueberry powder
|
Placebo
n=26 Participants
Placebo: 22 g placebo blueberry powder
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 1.1 • n=99 Participants
|
66.7 years
STANDARD_DEVIATION 1.1 • n=107 Participants
|
67.0 years
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 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
|
|
Blood Pressure
Systolic blood pressure
|
130.3 mm Hg
STANDARD_DEVIATION 21.7 • n=99 Participants
|
126.2 mm Hg
STANDARD_DEVIATION 13.3 • n=107 Participants
|
128.2 mm Hg
STANDARD_DEVIATION 18.0 • n=206 Participants
|
|
Blood Pressure
Diastolic blood pressure
|
73.4 mm Hg
STANDARD_DEVIATION 5.4 • n=99 Participants
|
76.2 mm Hg
STANDARD_DEVIATION 7.8 • n=107 Participants
|
74.8 mm Hg
STANDARD_DEVIATION 6.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksSystolic blood pressure and diastolic blood pressure.
Outcome measures
| Measure |
Blueberry
n=26 Participants
Blueberry: 22 g freeze-dried whole blueberry powder
|
Placebo
n=26 Participants
Placebo: 22 g placebo blueberry powder
|
|---|---|---|
|
Blood Pressure
Systolic blood pressure
|
125.6 mm Hg
Standard Error 2.5
|
126.0 mm Hg
Standard Error 2.5
|
|
Blood Pressure
Diastolic blood pressure
|
74.6 mm Hg
Standard Error 1.0
|
75.1 mm Hg
Standard Error 1.0
|
SECONDARY outcome
Timeframe: 8 weeksHemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.
Outcome measures
| Measure |
Blueberry
n=26 Participants
Blueberry: 22 g freeze-dried whole blueberry powder
|
Placebo
n=26 Participants
Placebo: 22 g placebo blueberry powder
|
|---|---|---|
|
Hemoglobin A1C
|
7.1 percent
Standard Error 0.1
|
7.5 percent
Standard Error 0.2
|
Adverse Events
Blueberry
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Margaret M. Wilson MS, RD, LD/N, CD/N, CNSC, CDE
Stratton V.A. Medical Center
Phone: 518 626-6889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place