CClinicalTrials.gg
CompletedNCT02139878Updated Mar 28, 2017Results posted

Short-term Health Effects of Wild Blueberry Juice Consumption

An interventional study of Wild blueberry juice and Placebo wild blueberry juice in Pre-diabetes, sponsored by University of Prince Edward Island. Completed at 1 site in Canada. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by University of Prince Edward Island · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice.

02

Conditions studied

  • Pre-diabetes

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03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's enrollment of 20 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

University of Prince Edward Island is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy individuals at risk for type 2 diabetes

Exclusion criteria

Exclusion Criteria:

  • have a body mass index of less than 20 and greater than 45 kg/m2.
  • are less than 21 and greater than 65 years old at beginning of study
  • have smoked or used tobacco within 6 months prior to the start of the study
  • are pregnant, plan to become pregnant or become pregnant during the study
  • have a history or presence of kidney disease, liver disease, certain cancers, gastrointestinal, other metabolic diseases, or malabsorption syndromes
  • have type 2 diabetes and need to use oral diabetic drugs or insulin
  • have an allergy or adverse reaction to blueberries
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Wild blueberry juice

    240 ml wild blueberry juice

    Other: Wild blueberry juice

  • Placebo comparator
    Placebo wild blueberry juice

    240 ml placebo wild blueberry juice

    Other: Placebo wild blueberry juice

Interventions

  • OtherWild blueberry juice
  • OtherPlacebo wild blueberry juice
06

What researchers measure

Primary outcomes

  1. Blood Pressure

    Systolic blood pressure

    Time frame: Up to 4 weeks

Secondary outcomes

  1. Glucose

    Plasma blood glucose concentrations

    Time frame: Up to 4 weeks

07

Results

Posted Feb 17, 2017

Participant flow

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

First Intervention (7 Days)
Participant flow — First Intervention (7 Days)
MilestoneWild Blueberry Juice First, Then PlaceboPlacebo First, Then Wild Blueberry Juice
Started1010
Completed910
Not completed10
Washout Period (8 Days)
Participant flow — Washout Period (8 Days)
MilestoneWild Blueberry Juice First, Then PlaceboPlacebo First, Then Wild Blueberry Juice
Started910
Completed910
Not completed00
Second Intervention (7 Days)
Participant flow — Second Intervention (7 Days)
MilestoneWild Blueberry Juice First, Then PlaceboPlacebo First, Then Wild Blueberry Juice
Started910
Completed910
Not completed00

Outcome measures

PrimaryBlood Pressure

Systolic blood pressure

Time frame:
Up to 4 weeks
Reported as:
Mean · mm Hg
Blood Pressure
mm HgWild Blueberry JuicePlacebo
Blood Pressure116.0 ± 2.2120.8 ± 2.2
Statistical analysis
  • Wild Blueberry Juice vs Placebo · ANCOVA · p = =0.088
SecondaryGlucose

Plasma blood glucose concentrations

Time frame:
Up to 4 weeks
Reported as:
Mean · mmol/L
Glucose
mmol/LWild Blueberry JuicePlacebo
Glucose5.3 ± 0.15.4 ± 0.1
Statistical analysis
  • Wild Blueberry Juice vs Placebo · ANCOVA · p = =0.980

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Wild Blueberry Juice—0/19 (0%)0/19 (0%)
Placebo—0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Entire Study Population
Mean53 ± 6.3
Sex: Female, Male
Sex: Female, Male(Participants)Entire Study Population
Female19
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Entire Study Population
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White19
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Entire Study Population
Canada19
08

Study locations

1 site
  • University of Prince Edward Island, Health Sciences
    Charlottetown, Prince Edward Island C1A 4P3, Canada
09

References and documents

Publications

  • Stote KS, Sweeney MI, Kean T, Baer DJ, Novotny JA, Shakerley NL, Chandrasekaran A, Carrico PM, Melendez JA, Gottschall-Pass KT. The effects of 100% wild blueberry (Vaccinium angustifolium) juice consumption on cardiometablic biomarkers: a randomized, placebo-controlled, crossover trial in adults with increased risk for type 2 diabetes. BMC Nutr. 2017 May 25;3:45. doi: 10.1186/s40795-017-0164-0. eCollection 2017. PubMed 32153825 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02139878
Lead sponsor
University of Prince Edward Island
Responsible party
Kim Stote (Research Chair of Nutrisciences and Health, University of Prince Edward Island) — Principal investigator
First posted
May 15, 2014
Start date
May 2014
Primary completion
Jun 2015
Completion
Jun 2015
Results posted
Feb 17, 2017
Last update
Mar 28, 2017

Study contacts

Katherine Gottschall-Pass, PhD, RD
principal investigator · University of Prince Edward Island

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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