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NCT Number: NCT02972996

Blueberry Consumption and Type 2 Diabetes

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.

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Key information

Conditions

Type2 Diabetes

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stratton V.A. Medical Center

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blueberry

Other

22 g freeze-dried whole blueberry powder

Placebo

Other

22 g placebo blueberry powder

Primary outcomes

  1. Blood Pressure

    Time frame: 8 weeks

    Systolic blood pressure and diastolic blood pressure.

Secondary outcomes

  1. Hemoglobin A1C

    Time frame: 8 weeks

    Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.

Sponsors and collaborators

Lead sponsor

Albany Research Institute, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2016
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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