NCT02972996

Blueberry Consumption and Type 2 Diabetes

Completed NA Results posted Last updated 19 April 2022

What this trial tests

NA trial testing Blueberry in Type2 Diabetes in 55 participants. Completed in 21 June 2018.

Timeline

19 January 2017

Primary endpoint
21 June 2018

21 June 2018

Quick facts

Lead sponsor	Albany Research Institute, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	55
Start date	19 January 2017
Primary completion	21 June 2018
Estimated completion	21 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Blueberry
• Placebo

Conditions studied

• Type2 Diabetes — all drugs for Type2 Diabetes →

Sponsor

Albany Research Institute, Inc.

Who can join

Adults 45 to 75, male only, with Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Blood Pressure Primary · 8 weeks

Systolic blood pressure and diastolic blood pressure.

Systolic blood pressure

Group	Value	95% CI
Blueberry	125.6	± 2.5
Placebo	126.0	± 2.5

Diastolic blood pressure

Group	Value	95% CI
Blueberry	74.6	± 1.0
Placebo	75.1	± 1.0

Hemoglobin A1C Secondary · 8 weeks

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

Group	Value	95% CI
Blueberry	7.1	± 0.1
Placebo	7.5	± 0.2

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dietary Anthocyanins and Insulin Resistance: When Food Becomes a Medicine.
   Belwal T, Nabavi SF, Nabavi SM, Habtemariam S. · · 2017 · cited 94× · PMID 29023424 · DOI 10.3390/nu9101111
2. Effect of Blueberry Consumption on Cardiometabolic Health Parameters in Men with Type 2 Diabetes: An 8-Week, Double-Blind, Randomized, Placebo-Controlled Trial.
   Stote KS, Wilson MM, Hallenbeck D, Thomas K, et al · · 2020 · cited 49× · PMID 32337475 · DOI 10.1093/cdn/nzaa030
3. The Dash Diet Pattern and Blood Pressure Changes in US Veterans With Type 2 Diabetes – a Post-hoc Analysis of the Blueberry Consumption and Type 2 Diabetes Study
   · 2022