Anti-Obesity Effect of Pediococcus Pentosaceus LP28

February 25, 2016 updated by: Fumiko Higashikawa, Hiroshima University

A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity

This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 734-8551
        • Hiroshima University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 25-30 kg/m2

Exclusion Criteria:

  • Taking medicines 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Experimental: Live Pediococcus pentosaceus LP28
Dietary supplement: Live Pediococcus pentosaceus LP28
Experimental: Heat-killed Pediococcus pentosaceus LP28
Dietary supplement: Heat-killed Pediococcus pentosaceus LP28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
BMI
Time Frame: Every day (Overall 14 weeks)
Body weight will be measured every morning.
Every day (Overall 14 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Abdominal circumference
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
Serum triglyceride
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
Total cholesterol
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
LDL cholesterol
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
HDL cholesterol
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
Fasting blood glucose
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
Fasting insulin
Time Frame: Weeks 0 and 12
Weeks 0 and 12
HOMA-R
Time Frame: Weeks 0 and 12
Weeks 0 and 12
Adiponectin
Time Frame: Weeks 0 and 12
Weeks 0 and 12
Leptin
Time Frame: Weeks 0 and 12
Weeks 0 and 12
Resistin
Time Frame: Weeks 0 and 12
Weeks 0 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hiroshima University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimate)

September 14, 2012

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eki-619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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