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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedAugust 11, 2014
August 1, 2014
6 months
January 29, 2014
August 7, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
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 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)
- +5 more secondary outcomes
Study Arms (2)
Koji-extracted beverage
PLACEBO COMPARATOR100ml/day for 12 weeks
Koji-extracted beverage fermented with LP28
EXPERIMENTAL100ml/day for 12 weeks. 1x10\^11 cells (LP28)/day
Interventions
Eligibility Criteria
You may qualify if:
- BMI 25-30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hiroshima Universitylead
- Marukome Co., Ltd.collaborator
Study Sites (1)
Hiroshima University
Hiroshima, Hiroshima, 734-8551, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fumiko Higashikawa, PhD
Hiroshima University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 29, 2014
First Posted
January 30, 2014
Study Start
December 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 11, 2014
Record last verified: 2014-08