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

NCT ID: NCT02023320

Last Updated: 2014-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low dose of blueberry dry powder

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

Group Type EXPERIMENTAL

Low dose of blueberry dry powder

Intervention Type DIETARY_SUPPLEMENT

High dose of blueberry dry powder

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

Group Type EXPERIMENTAL

High dose of blueberry dry powder

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Low dose of blueberry dry powder

Intervention Type DIETARY_SUPPLEMENT

High dose of blueberry dry powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agricultural Producers' Cooperative Corporation Shinpo-en

UNKNOWN

Sponsor Role collaborator

Hiroshima University

OTHER

Sponsor Role lead

Responsible Party

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Fumiko Higashikawa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fumiko Higashikawa, PhD

Role: PRINCIPAL_INVESTIGATOR

Hiroshima University

Locations

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Hiroshima University

Hiroshima, Hiroshima, Japan

Site Status

Countries

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Japan

Other Identifiers

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eki-842

Identifier Type: -

Identifier Source: org_study_id

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