Anti-Obesity Effect of Pediococcus Pentosaceus LP28 | NCT01685944

Studies
Anti-Obesity Effect of Pediococcus Pentosaceus LP28

NCT01685944

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Feb 26, 2016Estimated

Enrollment

62Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Live Pediococcus pentosaceus LP28
Heat-killed Pediococcus pentosaceus LP28
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

Feb 2016

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

Aug 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Sep 12, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 14, 2012Estimated

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

Feb 25, 2016

Last Update Posted Date

Feb 26, 2016Estimated

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

This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2.

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

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Dietary Supplement: Placebo
Live Pediococcus pentosaceus LP28	Experimental	Dietary Supplement: Live Pediococcus pentosaceus LP28
Heat-killed Pediococcus pentosaceus LP28	Experimental	Dietary Supplement: Heat-killed Pediococcus pentosaceus LP28

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Live Pediococcus pentosaceus LP28	Dietary Supplement		Live Pediococcus pentosaceus LP28
Heat-killed Pediococcus pentosaceus LP28

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body fat		Every 4 weeks (Overall 12 weeks)
BMI	Body weight will be measured every morning.	Every day (Overall 14 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Abdominal circumference		Every 4 weeks (Overall 12 weeks)
Serum triglyceride		Every 4 weeks (Overall 12 weeks)
Total cholesterol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 25-30 kg/m2

Exclusion Criteria:

Taking medicines or functional food that may affect body weight or body fat
Pregnant or nursing a child
Participation in any clinical trial within 90 days of the commencement of the trial
Renal or hepatic dysfunction
Heart disease

Accepts Healthy Volunteers

Yes

Sex

All

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

Name	Affiliation	Role
Fumiko Higashikawa, PhD	Hiroshima University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		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