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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050555
• Other study ID #: eki-867
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: August 7, 2014
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• 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 the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• 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 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 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

• Overweight

Intervention

Dietary Supplement:
• Placebo

• Koji-extracted beverage fermented with Pediococcus pentosaceus LP28

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	Marukome Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI from baseline		Every 4 weeks (Overall 12 weeks)	No
Primary	Change in body fat mass (percentage) from baseline		Every 4 weeks (Overall 12 weeks)	No
Secondary	Change in abdominal circumference from baseline		Every 4 weeks (Overall 12 weeks)	No
Secondary	Change in visceral fat area by CT scan from baseline		Weeks 0 and 12	No
Secondary	Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline		Weeks 0 and 12	No
Secondary	Change in fasting plasma glucose from baseline		Every 4 weeks (Overall 12 weeks)	No
Secondary	Change in serum triglyceride from baseline		Every 4 weeks (Overall 12 weeks)	No
Secondary	Change in serum total cholesterol from baseline		Every 4 weeks (Overall 12 weeks)	No
Secondary	Change in serum LDL cholesterol from baseline		Every 4 weeks (Overall 12 weeks)	No
Secondary	Change in serum HDL cholesterol from baseline		Every 4 weeks (Overall 12 weeks)	No
Secondary	Change in fasting insulin from baseline		Weeks 0 and 12	No
Secondary	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	No