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Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

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ClinicalTrials.gov Identifier: NCT00880958
Recruitment Status : Completed
First Posted : April 14, 2009
Last Update Posted : October 29, 2009
Sponsor:
Collaborators:
Biostir, Inc.
MIONA Co., Ltd.
Information provided by:
Hiroshima University

Brief Summary:
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 or disease Intervention/treatment
Obesity Dietary Supplement: Mixture of various probiotics and fermentation products Dietary Supplement: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial
Study Start Date : March 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Dietary Supplement: Mixture of various probiotics and fermentation products
Placebo Comparator: 2 Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Body mass index [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Body fat mass [ Time Frame: Week -4, Week 0, Week 4, Week 12 ]
  2. Abdominal circumference [ Time Frame: Week -4, Week 0, Week 4, Week 12 ]
  3. Visceral fat area by CT scan [ Time Frame: Week 0, Week 12 ]
  4. Intestinal flora [ Time Frame: Week 0, Week 12 ]
  5. Serum lipid profile [ Time Frame: Week -4, Week 0, Week 4, Week 12 ]
  6. Serum adiponectin and leptin levels [ Time Frame: Week 0, Week 12 ]
  7. Fasting serum glucose and HbA1c levels [ Time Frame: Week -4, Week 0, Week 4, Week 12 ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880958


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

Responsible Party: Fumiko Higashikawa, PhD/Associate professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT00880958     History of Changes
Other Study ID Numbers: eki-123
First Posted: April 14, 2009    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009

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