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Clinical Trials/NCT02972996
NCT02972996
Completed
Not Applicable

Effects of Blueberry Consumption on Cardiometabolic Parameters in Men With Type 2 Diabetes.

Albany Research Institute, Inc.1 site in 1 country55 target enrollmentJanuary 19, 2017
ConditionsType2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type2 Diabetes
Sponsor
Albany Research Institute, Inc.
Enrollment
55
Locations
1
Primary Endpoint
Blood Pressure
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 19, 2017
End Date
June 21, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Blood Pressure

Time Frame: 8 weeks

Systolic blood pressure and diastolic blood pressure.

Secondary Outcomes

  • Hemoglobin A1C(8 weeks)

Study Sites (1)

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