Back to resultsAnti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Koji-extracted beverage fermented with Pediococcus pentosaceus LP28
Sponsored by
About this trial
This is an interventional prevention trial for Overweight
Eligibility Criteria
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
Sites / Locations
- Hiroshima University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Koji-extracted beverage
Koji-extracted beverage fermented with LP28
Arm Description
100ml/day for 12 weeks
100ml/day for 12 weeks. 1x10^11 cells (LP28)/day
Outcomes
Primary Outcome Measures
Change in BMI from baseline
Change in body fat mass (percentage) from baseline
Secondary Outcome Measures
Change in abdominal circumference from baseline
Change in visceral fat area by CT scan from baseline
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Change in fasting plasma glucose from baseline
Change in serum triglyceride from baseline
Change in serum total cholesterol from baseline
Change in serum LDL cholesterol from baseline
Change in serum HDL cholesterol from baseline
Change in fasting insulin from baseline
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
Full Information
NCT ID
NCT02050555
First Posted
January 29, 2014
Last Updated
August 7, 2014
Sponsor
Hiroshima University
Collaborators
Marukome Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02050555
Brief Title
Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
Official Title
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima University
Collaborators
Marukome Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Koji-extracted beverage
Arm Type
Placebo Comparator
Arm Description
100ml/day for 12 weeks
Arm Title
Koji-extracted beverage fermented with LP28
Arm Type
Experimental
Arm Description
100ml/day for 12 weeks. 1x10^11 cells (LP28)/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Koji-extracted beverage fermented with Pediococcus pentosaceus LP28
Primary Outcome Measure Information:
Title
Change in BMI from baseline
Time Frame
Every 4 weeks (Overall 12 weeks)
Title
Change in body fat mass (percentage) from baseline
Time Frame
Every 4 weeks (Overall 12 weeks)
Secondary Outcome Measure Information:
Title
Change in abdominal circumference from baseline
Time Frame
Every 4 weeks (Overall 12 weeks)
Title
Change in visceral fat area by CT scan from baseline
Time Frame
Weeks 0 and 12
Title
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Time Frame
Weeks 0 and 12
Title
Change in fasting plasma glucose from baseline
Time Frame
Every 4 weeks (Overall 12 weeks)
Title
Change in serum triglyceride from baseline
Time Frame
Every 4 weeks (Overall 12 weeks)
Title
Change in serum total cholesterol from baseline
Time Frame
Every 4 weeks (Overall 12 weeks)
Title
Change in serum LDL cholesterol from baseline
Time Frame
Every 4 weeks (Overall 12 weeks)
Title
Change in serum HDL cholesterol from baseline
Time Frame
Every 4 weeks (Overall 12 weeks)
Title
Change in fasting insulin from baseline
Time Frame
Weeks 0 and 12
Title
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
Description
HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
Time Frame
Weeks 0 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fumiko Higashikawa, PhD
Organizational Affiliation
Hiroshima University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hiroshima University
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
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