Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

October 28, 2009 updated by: Hiroshima University

Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial

The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy as based on medical history and physical examination
  • BMI between 25 and 30 kg/m2
  • Willing not to serve as blood donor during the study
  • Informed consent signed

Exclusion Criteria:

  • Food allergy
  • Female subjects who are pregnant or nursing a child
  • Participation in any clinical trial up to 90 days before Day 01 of this study
  • Renal or hepatic dysfunction
  • Heart disease
  • Under medication
  • Subjects who are taking functional food designed for weight loss or serum lipid reduction

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Dietary supplement: Placebo
EXPERIMENTAL: 1
Dietary supplement: Mixture of various probiotics and fermentation products

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body mass index
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum adiponectin and leptin levels
Time Frame: Week 0, Week 12
Week 0, Week 12
Body fat mass
Time Frame: Week -4, Week 0, Week 4, Week 12
Week -4, Week 0, Week 4, Week 12
Abdominal circumference
Time Frame: Week -4, Week 0, Week 4, Week 12
Week -4, Week 0, Week 4, Week 12
Visceral fat area by CT scan
Time Frame: Week 0, Week 12
Week 0, Week 12
Intestinal flora
Time Frame: Week 0, Week 12
Week 0, Week 12
Serum lipid profile
Time Frame: Week -4, Week 0, Week 4, Week 12
Week -4, Week 0, Week 4, Week 12
Fasting serum glucose and HbA1c levels
Time Frame: Week -4, Week 0, Week 4, Week 12
Week -4, Week 0, Week 4, Week 12

Collaborators and Investigators

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

Sponsor

Hiroshima University

Collaborators

Biostir, Inc.
MIONA Co., Ltd.

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

March 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

April 13, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (ESTIMATE)

April 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2009

Last Update Submitted That Met QC Criteria

October 28, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eki-123

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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