Effect of the Extract of the Flour Fermented With Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose

NCT ID: NCT02300181

Last Updated: 2015-08-19

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of the present study is to evaluate the effect of the extract of the flour fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level 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

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo (flour)

5 placebo capsules for each test (4.88 kcal/5 cap)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Bacillus subtilis var natto DC-15

5 experimental capsules for each test (4.96 kcal/5 cap) Extract powder of the flour fermented with Bacillus subtilis var natto DC-15

Group Type EXPERIMENTAL

Bacillus subtilis var natto DC-15

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo

Intervention Type DIETARY_SUPPLEMENT

Bacillus subtilis var natto DC-15

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
* 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
* History of severe disease and/or major surgery
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NewBio Enterprise Co., ltd.

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, , Japan

Site Status

Countries

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Japan

Other Identifiers

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eki-1051

Identifier Type: -

Identifier Source: org_study_id

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