Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

NCT ID: NCT02050555

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

2013-12-31

Study Completion Date

2014-06-30

Brief Summary

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This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.

Detailed Description

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Conditions

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Overweight

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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Koji-extracted beverage

100ml/day for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Koji-extracted beverage fermented with LP28

100ml/day for 12 weeks. 1x10\^11 cells (LP28)/day

Group Type EXPERIMENTAL

Koji-extracted beverage fermented with Pediococcus pentosaceus LP28

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo

Intervention Type DIETARY_SUPPLEMENT

Koji-extracted beverage fermented with Pediococcus pentosaceus LP28

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI 25-30 kg/m2

Exclusion Criteria

* Taking drugs or functional food that may affect body weight or body fat
* 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

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marukome 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, Hiroshima, Japan

Site Status

Countries

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Japan

Other Identifiers

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eki-867

Identifier Type: -

Identifier Source: org_study_id

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