Blueberry Consumption and Type 2 Diabetes

NCT02972996 | Completed Results DMC

• 1 other identifier: HNS 01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Systolic blood pressure and diastolic blood pressure.

  8 weeks

Secondary Outcomes (1)

• Hemoglobin A1C

  8 weeks

Study Arms (2)

Blueberry

EXPERIMENTAL

22 g freeze-dried blueberries

Other: Blueberry

Placebo

PLACEBO COMPARATOR

22 g placebo

Other: Placebo

Interventions

Blueberry OTHER

22 g freeze-dried whole blueberry powder

Blueberry

Placebo OTHER

22 g placebo blueberry powder

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Research Institute, Inc.: lead

Study Sites (1)

Stratton V.A. Medical Center

Albany, New York, 12208, United States

Location

Related Publications (1)

• 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.

  PMID: 32337475 DERIVED

MeSH Terms

Interventions

blueberry extract

Results Point of Contact

• Title: Margaret M. Wilson MS, RD, LD/N, CD/N, CNSC, CDE
• Organization: Stratton V.A. Medical Center

margaret.wilson2@va.gov

518 626-6889

Study Officials

• Margaret M. Wilson, MS, RD, CDE

  Stratton V.A. Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: January 19, 2017
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: April 19, 2022
• Results First Posted: April 19, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)