Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Koji-extracted beverage fermented with Pediococcus pentosaceus LP28

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan, 734-8551
    • Hiroshima University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI 25-30 kg/m2

Exclusion Criteria:

• Taking drugs 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
• History of severe disease and/or major surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Koji-extracted beverage; 100ml/day for 12 weeks	Dietary supplement: Placebo
Experimental: Koji-extracted beverage fermented with LP28; 100ml/day for 12 weeks. 1x10^11 cells (LP28)/day	Dietary supplement: Koji-extracted beverage fermented with Pediococcus pentosaceus LP28

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in BMI from baseline	Every 4 weeks (Overall 12 weeks)
Change in body fat mass (percentage) from baseline	Every 4 weeks (Overall 12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline		Weeks 0 and 12
Change in fasting insulin from baseline		Weeks 0 and 12
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline	HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405	Weeks 0 and 12
Change in abdominal circumference from baseline		Every 4 weeks (Overall 12 weeks)
Change in visceral fat area by CT scan from baseline		Weeks 0 and 12
Change in fasting plasma glucose from baseline		Every 4 weeks (Overall 12 weeks)
Change in serum triglyceride from baseline		Every 4 weeks (Overall 12 weeks)
Change in serum total cholesterol from baseline		Every 4 weeks (Overall 12 weeks)
Change in serum LDL cholesterol from baseline		Every 4 weeks (Overall 12 weeks)
Change in serum HDL cholesterol from baseline		Every 4 weeks (Overall 12 weeks)

Collaborators and Investigators

• Sponsor: Hiroshima University
• Collaborators: Marukome Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 29, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: August 7, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: eki-867