Blueberry Consumption and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Other: Placebo; Other: Blueberry

• Registration Number: NCT02972996
• Lead Sponsor: Albany Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-25
• Study Start: 2017-01-19
• Primary Completion: 2018-06-21
• Study Completion: 2018-06-21
• Results First Submitted: 2019-10-01
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Results First Posted: 2022-04-19
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	22 g placebo
Blueberry	Blueberry	22 g freeze-dried blueberries

Primary Outcome Measures

Name	Time	Method
Blood Pressure	8 weeks	Systolic blood pressure and diastolic blood pressure.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1C	8 weeks	Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.

Trial Locations

Locations (1)

Stratton V.A. Medical Center; 🇺🇸 Albany, New York, United States