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Blueberry Consumption and Type 2 Diabetes

A

Albany Research Institute, Inc.

Status

Completed

Conditions

Type2 Diabetes

Treatments

Other: Placebo
Other: Blueberry

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

Male

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

55 participants in 2 patient groups, including a placebo group

Blueberry
Experimental group
Description:
22 g freeze-dried blueberries
Treatment:
Other: Blueberry
Placebo
Placebo Comparator group
Description:
22 g placebo
Treatment:
Other: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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