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Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

This study has been completed.
Sponsor:
Collaborators:
Biostir, Inc.
MIONA Co., Ltd.
Information provided by:
Hiroshima University
ClinicalTrials.gov Identifier:
NCT00880958
First received: April 13, 2009
Last updated: October 28, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Dietary Supplement: Mixture of various probiotics and fermentation products
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Body mass index [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body fat mass [ Time Frame: Week -4, Week 0, Week 4, Week 12 ] [ Designated as safety issue: No ]
  • Abdominal circumference [ Time Frame: Week -4, Week 0, Week 4, Week 12 ] [ Designated as safety issue: No ]
  • Visceral fat area by CT scan [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
  • Intestinal flora [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
  • Serum lipid profile [ Time Frame: Week -4, Week 0, Week 4, Week 12 ] [ Designated as safety issue: No ]
  • Serum adiponectin and leptin levels [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
  • Fasting serum glucose and HbA1c levels [ Time Frame: Week -4, Week 0, Week 4, Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2009
Study Completion Date: September 2009
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Mixture of various probiotics and fermentation products
Placebo Comparator: 2 Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880958

Locations
Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Biostir, Inc.
MIONA Co., Ltd.
  More Information

No publications provided

Responsible Party: Fumiko Higashikawa, PhD/Associate professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT00880958     History of Changes
Other Study ID Numbers: eki-123
Study First Received: April 13, 2009
Last Updated: October 28, 2009
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013