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Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Low dose of blueberry dry powder
High dose of blueberry dry powder
Sponsored by
Hiroshima University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Fasting plasma glucose 110-125 mg/dL

Exclusion Criteria:

  • Taking anti-diabetic drugs
  • Taking drugs or functional food that may affect blood glucose level
  • Fruit allergy
  • Pregnant or nursing a child
  • Participation in any clinical trial within 90 days of the commencement of the trial
  • Renal or hepatic dysfunction
  • Heart disease

Sites / Locations

  • Hiroshima University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low dose of blueberry dry powder

High dose of blueberry dry powder

Arm Description

0.5 g blueberry dry powder, twice a day for 12 weeks

5.0 g blueberry dry powder, twice a day for 12 weeks

Outcomes

Primary Outcome Measures

Change in fasting plasma glucose from baseline
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Change in HbA1c from baseline

Secondary Outcome Measures

Change in glycoalbumin from baseline
Change in fasting insulin from baseline
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
Change in serum C-peptide from baseline

Full Information

First Posted
December 17, 2013
Last Updated
August 7, 2014
Sponsor
Hiroshima University
Collaborators
Agricultural Producers' Cooperative Corporation Shinpo-en
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1. Study Identification

Unique Protocol Identification Number
NCT02023320
Brief Title
Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes
Official Title
A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Blueberry Dry Powder on Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima University
Collaborators
Agricultural Producers' Cooperative Corporation Shinpo-en

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose of blueberry dry powder
Arm Type
Experimental
Arm Description
0.5 g blueberry dry powder, twice a day for 12 weeks
Arm Title
High dose of blueberry dry powder
Arm Type
Experimental
Arm Description
5.0 g blueberry dry powder, twice a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Low dose of blueberry dry powder
Intervention Type
Dietary Supplement
Intervention Name(s)
High dose of blueberry dry powder
Primary Outcome Measure Information:
Title
Change in fasting plasma glucose from baseline
Time Frame
Every 6 weeks (Overall 12 weeks)
Title
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Time Frame
Weeks 0 and 12
Title
Change in HbA1c from baseline
Time Frame
Weeks 0 and 12
Secondary Outcome Measure Information:
Title
Change in glycoalbumin from baseline
Time Frame
Every 6 weeks (Overall 12 weeks)
Title
Change in fasting insulin from baseline
Time Frame
Weeks 0 and 12
Title
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
Description
HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
Time Frame
Weeks 0 and 12
Title
Change in serum C-peptide from baseline
Time Frame
Weeks 0 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fasting plasma glucose 110-125 mg/dL Exclusion Criteria: Taking anti-diabetic drugs Taking drugs or functional food that may affect blood glucose level Fruit allergy Pregnant or nursing a child Participation in any clinical trial within 90 days of the commencement of the trial Renal or hepatic dysfunction Heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fumiko Higashikawa, PhD
Organizational Affiliation
Hiroshima University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hiroshima University
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan

12. IPD Sharing Statement

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Effects of Blueberry Dry Powder on Glycemic Status in Subjects With Prediabetes

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