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Short-term Health Effects of Wild Blueberry Juice Consumption

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wild blueberry juice
Placebo wild blueberry juice
Sponsored by
University of Prince Edward Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pre-diabetes

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy individuals at risk for type 2 diabetes

Exclusion Criteria:

  • have a body mass index of less than 20 and greater than 45 kg/m2.
  • are less than 21 and greater than 65 years old at beginning of study
  • have smoked or used tobacco within 6 months prior to the start of the study
  • are pregnant, plan to become pregnant or become pregnant during the study
  • have a history or presence of kidney disease, liver disease, certain cancers, gastrointestinal, other metabolic diseases, or malabsorption syndromes
  • have type 2 diabetes and need to use oral diabetic drugs or insulin
  • have an allergy or adverse reaction to blueberries

Sites / Locations

  • University of Prince Edward Island, Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Wild blueberry juice

Placebo wild blueberry juice

Arm Description

240 ml wild blueberry juice

240 ml placebo wild blueberry juice

Outcomes

Primary Outcome Measures

Blood Pressure
Systolic blood pressure

Secondary Outcome Measures

Glucose
Plasma blood glucose concentrations

Full Information

First Posted
May 4, 2014
Last Updated
February 24, 2017
Sponsor
University of Prince Edward Island
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1. Study Identification

Unique Protocol Identification Number
NCT02139878
Brief Title
Short-term Health Effects of Wild Blueberry Juice Consumption
Official Title
Short-term Health Effects of Wild Blueberry Juice Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Prince Edward Island

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Researchers at the University of Prince Edward Island want to learn about the health effects of wild blueberry juice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wild blueberry juice
Arm Type
Experimental
Arm Description
240 ml wild blueberry juice
Arm Title
Placebo wild blueberry juice
Arm Type
Placebo Comparator
Arm Description
240 ml placebo wild blueberry juice
Intervention Type
Other
Intervention Name(s)
Wild blueberry juice
Intervention Type
Other
Intervention Name(s)
Placebo wild blueberry juice
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic blood pressure
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Glucose
Description
Plasma blood glucose concentrations
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals at risk for type 2 diabetes Exclusion Criteria: have a body mass index of less than 20 and greater than 45 kg/m2. are less than 21 and greater than 65 years old at beginning of study have smoked or used tobacco within 6 months prior to the start of the study are pregnant, plan to become pregnant or become pregnant during the study have a history or presence of kidney disease, liver disease, certain cancers, gastrointestinal, other metabolic diseases, or malabsorption syndromes have type 2 diabetes and need to use oral diabetic drugs or insulin have an allergy or adverse reaction to blueberries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Gottschall-Pass, PhD, RD
Organizational Affiliation
University of Prince Edward Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Prince Edward Island, Health Sciences
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 4P3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32153825
Citation
Stote KS, Sweeney MI, Kean T, Baer DJ, Novotny JA, Shakerley NL, Chandrasekaran A, Carrico PM, Melendez JA, Gottschall-Pass KT. The effects of 100% wild blueberry (Vaccinium angustifolium) juice consumption on cardiometablic biomarkers: a randomized, placebo-controlled, crossover trial in adults with increased risk for type 2 diabetes. BMC Nutr. 2017 May 25;3:45. doi: 10.1186/s40795-017-0164-0. eCollection 2017.
Results Reference
derived

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Short-term Health Effects of Wild Blueberry Juice Consumption

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