Effects of Supplement Containing Various Probiotics and F... | NCT00880958

Studies
Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

NCT00880958

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Oct 29, 2009Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

Mixture of various probiotics and fermentation products
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Not provided

Completion Date

Sep 2009Actual

First Submitted Date

Apr 13, 2009

First Submission Date that Met QC Criteria

Apr 13, 2009

First Posted Date

Apr 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2009

Last Update Posted Date

Oct 29, 2009Estimated

Name	Class
Biostir, Inc.	INDUSTRY
MIONA Co., Ltd.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Dietary Supplement: Mixture of various probiotics and fermentation products
2	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mixture of various probiotics and fermentation products	Dietary Supplement		1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body mass index		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Body fat mass		Week -4, Week 0, Week 4, Week 12
Abdominal circumference		Week -4, Week 0, Week 4, Week 12
Visceral fat area by CT scan

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima	Hiroshima	734-8551	Japan

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided