Anti-Obesity Effect of Pediococcus Pentosaceus LP28

Obesity Clinical Trial

Official title:

A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685944
• Other study ID #: eki-619
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: February 25, 2016
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2016
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Live Pediococcus pentosaceus LP28

• Heat-killed Pediococcus pentosaceus LP28

• Placebo

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (1)

Lead Sponsor	Collaborator
Hiroshima University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fat		Every 4 weeks (Overall 12 weeks)	No
Primary	BMI	Body weight will be measured every morning.	Every day (Overall 14 weeks)	No
Secondary	Abdominal circumference		Every 4 weeks (Overall 12 weeks)	No
Secondary	Serum triglyceride		Every 4 weeks (Overall 12 weeks)	No
Secondary	Total cholesterol		Every 4 weeks (Overall 12 weeks)	No
Secondary	LDL cholesterol		Every 4 weeks (Overall 12 weeks)	No
Secondary	HDL cholesterol		Every 4 weeks (Overall 12 weeks)	No
Secondary	Fasting blood glucose		Every 4 weeks (Overall 12 weeks)	No
Secondary	Fasting insulin		Weeks 0 and 12	No
Secondary	HOMA-R		Weeks 0 and 12	No
Secondary	Adiponectin		Weeks 0 and 12	No
Secondary	Leptin		Weeks 0 and 12	No
Secondary	Resistin		Weeks 0 and 12	No