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Blueberry Consumption and Type 2 Diabetes

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry
Placebo
Sponsored by
Albany Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Stratton V.A. Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Blueberry

Placebo

Arm Description

22 g freeze-dried blueberries

22 g placebo

Outcomes

Primary Outcome Measures

Blood Pressure
Systolic blood pressure and diastolic blood pressure.

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2016
Last Updated
February 17, 2022
Sponsor
Albany Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02972996
Brief Title
Blueberry Consumption and Type 2 Diabetes
Official Title
Effects of Blueberry Consumption on Cardiometabolic Parameters in Men With Type 2 Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
June 21, 2018 (Actual)
Study Completion Date
June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albany Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blueberry
Arm Type
Experimental
Arm Description
22 g freeze-dried blueberries
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
22 g placebo
Intervention Type
Other
Intervention Name(s)
Blueberry
Intervention Description
22 g freeze-dried whole blueberry powder
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
22 g placebo blueberry powder
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic blood pressure and diastolic blood pressure.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin A1C
Description
Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret M. Wilson, MS, RD, CDE
Organizational Affiliation
Stratton V.A. Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stratton V.A. Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32337475
Citation
Stote KS, Wilson MM, Hallenbeck D, Thomas K, Rourke JM, Sweeney MI, Gottschall-Pass KT, Gosmanov AR. Effect of Blueberry Consumption on Cardiometabolic Health Parameters in Men with Type 2 Diabetes: An 8-Week, Double-Blind, Randomized, Placebo-Controlled Trial. Curr Dev Nutr. 2020 Mar 9;4(4):nzaa030. doi: 10.1093/cdn/nzaa030. eCollection 2020 Apr.
Results Reference
derived

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Blueberry Consumption and Type 2 Diabetes

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