Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880958
• Other study ID #: eki-123
• Status: Completed
• Phase: N/A
• First received: April 13, 2009
• Last updated: October 28, 2009
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Mixture of various probiotics and fermentation products

• Placebo

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (3)

Lead Sponsor	Collaborator
Hiroshima University	Biostir, Inc., MIONA Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index		16 weeks	No
Secondary	Body fat mass		Week -4, Week 0, Week 4, Week 12	No
Secondary	Abdominal circumference		Week -4, Week 0, Week 4, Week 12	No
Secondary	Visceral fat area by CT scan		Week 0, Week 12	No
Secondary	Intestinal flora		Week 0, Week 12	No
Secondary	Serum lipid profile		Week -4, Week 0, Week 4, Week 12	No
Secondary	Serum adiponectin and leptin levels		Week 0, Week 12	No
Secondary	Fasting serum glucose and HbA1c levels		Week -4, Week 0, Week 4, Week 12	No