Trial Outcomes & Findings for Short-term Health Effects of Wild Blueberry Juice Consumption (NCT NCT02139878)

NCT ID: NCT02139878

Last Updated: 2017-03-28

Results Overview

Systolic blood pressure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 4 weeks
• Results posted on: 2017-03-28

Participant Flow

74 individuals were screened for eligibility from the greater Charlottetown, Prince Edward Island, Canada area from March 2014 to May 2014.

20 of the 74 participants were randomized. Of those not randomized, 49 did not meet the inclusion criteria and 5 declined to participate.

Participant milestones

Measure	Wild Blueberry Juice First, Then Placebo 240 ml Wild Blueberry Juice daily first in intervention period and 240 ml Placebo beverage daily in second intervention period (after washout period)	Placebo First, Then Wild Blueberry Juice 240 ml Placebo beverage daily in first intervention period and 240 ml Wild Blueberry Juice daily in second intervention period (after washout period).
First Intervention (7 Days) STARTED	10	10
First Intervention (7 Days) COMPLETED	9	10
First Intervention (7 Days) NOT COMPLETED	1	0
Washout Period (8 Days) STARTED	9	10
Washout Period (8 Days) COMPLETED	9	10
Washout Period (8 Days) NOT COMPLETED	0	0
Second Intervention (7 Days) STARTED	9	10
Second Intervention (7 Days) COMPLETED	9	10
Second Intervention (7 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 participant was randomized but did not start the study

Baseline characteristics by cohort

Measure	Entire Study Population n=19 Participants Includes groups randomized to receive Wild Blueberry Juice first and Placebo first
Age, Continuous	53 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants • 1 participant was randomized but did not start the study
Sex: Female, Male Male	0 Participants n=5 Participants • 1 participant was randomized but did not start the study
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Systolic blood pressure

Outcome measures

Measure	Wild Blueberry Juice n=19 Participants 240 ml wild blueberry juice	Placebo n=19 Participants 240 ml placebo beverage
Blood Pressure	116.0 mm Hg Standard Error 2.2	120.8 mm Hg Standard Error 2.2

SECONDARY outcome

Timeframe: Up to 4 weeks

Plasma blood glucose concentrations

Outcome measures

Measure	Wild Blueberry Juice n=19 Participants 240 ml wild blueberry juice	Placebo n=19 Participants 240 ml placebo beverage
Glucose	5.3 mmol/L Standard Error 0.1	5.4 mmol/L Standard Error 0.1

Adverse Events

Wild Blueberry Juice

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

Kim S. Stote PhD, MPH, RD

University of Prince Edward Island

Phone: 518-587-2100

Email: Kim.Stote@esc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place