Pre-diabetes
Conditions
Brief summary
Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice.
Interventions
OTHERWild blueberry juice
OTHERPlacebo wild blueberry juice
Sponsors
University of Prince Edward Island
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy individuals at risk for type 2 diabetes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Up to 4 weeks | Systolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose | Up to 4 weeks | Plasma blood glucose concentrations |
Countries
Canada
Participant flow
Recruitment details
74 individuals were screened for eligibility from the greater Charlottetown, Prince Edward Island, Canada area from March 2014 to May 2014.
Pre-assignment details
20 of the 74 participants were randomized. Of those not randomized, 49 did not meet the inclusion criteria and 5 declined to participate.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive Wild Blueberry Juice first and Placebo first | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment Canada | 19 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Blood Pressure
Systolic blood pressure
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wild Blueberry Juice | Blood Pressure | 116.0 mm Hg | Standard Error 2.2 |
| Placebo | Blood Pressure | 120.8 mm Hg | Standard Error 2.2 |
p-value: =0.088ANCOVA
Secondary
Glucose
Plasma blood glucose concentrations
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wild Blueberry Juice | Glucose | 5.3 mmol/L | Standard Error 0.1 |
| Placebo | Glucose | 5.4 mmol/L | Standard Error 0.1 |
p-value: =0.98ANCOVA