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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02050555

Enrollment

Registered

2014-01-30

Start date

2013-12-31

Completion date

2014-06-30

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Brief 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.

Interventions

DIETARY_SUPPLEMENTPlacebo

DIETARY_SUPPLEMENTKoji-extracted beverage fermented with Pediococcus pentosaceus LP28

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026