Type2 Diabetes
Conditions
Brief summary
Lifestyle strategies that include dietary modification, such as consumption of a plant-based diet, are well recognized in disease prevention and may improve type 2 diabetes. Various components of a plant-based diet may contribute to its beneficial health effects, but there has been keen interest in the possibility that plant polyphenols may have a role. Blueberries are dietary sources of polyphenols, specifically anthocyanins. To date there are few human clinical trials evaluating the beneficial health effects of blueberries in populations with type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2 diabetes.
Interventions
OTHERBlueberry
22 g freeze-dried whole blueberry powder
OTHERPlacebo
22 g placebo blueberry powder
Sponsors
Albany Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male * Ages 45 to 75 years at beginning of study * BMI \>25 kg/m2 * HbA1C \> 6.5 and \< 9 * Medical diagnosis of type 2 diabetes for at least 6 months
Exclusion criteria
* Use of insulin * Presence of chronic kidney disease (GFR \< 45 mL/min), liver cirrhosis, gastrointestinal disease, pancreatic disease, or malabsorption syndromes * Weight loss of \>10% of body weight over the last 6 months; routine participation in heavy exercise * Heavy smokers (\>20 cigarettes per day) * Unable or unwilling to give informed consent or communicate with study staff * Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigators may interfere with study participation or the ability to follow the intervention protocol * Allergies to blueberries or blueberry products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 8 weeks | Systolic blood pressure and diastolic blood pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 8 weeks | Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blueberry Blueberry: 22 g freeze-dried whole blueberry powder | 26 |
| Placebo Placebo: 22 g placebo blueberry powder | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Blueberry | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 1.1 | 66.7 years STANDARD_DEVIATION 1.1 | 67.0 years STANDARD_DEVIATION 1.1 |
| Blood Pressure Diastolic blood pressure | 73.4 mm Hg STANDARD_DEVIATION 5.4 | 76.2 mm Hg STANDARD_DEVIATION 7.8 | 74.8 mm Hg STANDARD_DEVIATION 6.8 |
| Blood Pressure Systolic blood pressure | 130.3 mm Hg STANDARD_DEVIATION 21.7 | 126.2 mm Hg STANDARD_DEVIATION 13.3 | 128.2 mm Hg STANDARD_DEVIATION 18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Blood Pressure
Systolic blood pressure and diastolic blood pressure.
Time frame: 8 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Blueberry | Blood Pressure | Systolic blood pressure | 125.6 mm Hg | Standard Error 2.5 |
| Blueberry | Blood Pressure | Diastolic blood pressure | 74.6 mm Hg | Standard Error 1 |
| Placebo | Blood Pressure | Systolic blood pressure | 126.0 mm Hg | Standard Error 2.5 |
| Placebo | Blood Pressure | Diastolic blood pressure | 75.1 mm Hg | Standard Error 1 |
Comparison: Values are least-squares means ± SEs (adjusted for the baseline values) from ANCOVA linear mixed model that included covariates of age, baseline (pretreatment values), BMI and weight.p-value: 0.56ANCOVA
Secondary
Hemoglobin A1C
Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.
Time frame: 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Blueberry | Hemoglobin A1C | 7.1 percent | Standard Error 0.1 |
| Placebo | Hemoglobin A1C | 7.5 percent | Standard Error 0.2 |
p-value: 0.03ANCOVA