Blueberry Consumption and Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972996
• Other study ID #: HNS 01
• Status: Completed
• Phase: N/A
• Start date: January 19, 2017
• Est. completion date: June 21, 2018

Study information

• Verified date: February 2022
• Source: Albany Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Other:
• Blueberry
22 g freeze-dried whole blueberry powder
• Placebo
22 g placebo blueberry powder

Locations

Country	Name	City	State
United States	Stratton V.A. Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Systolic blood pressure and diastolic blood pressure.	8 weeks
Secondary	Hemoglobin A1C	Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.	8 weeks