OverweightNCT02050555
Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
A study testing Koji-extracted beverage fermented with Pediococcus pentosaceus LP28 in people with Overweight, run by Hiroshima University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Koji-extracted beverage fermented with Pediococcus pentosaceus LP28
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25-30 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight
- Being tested
- Placebo, Koji-extracted beverage fermented with Pediococcus pentosaceus LP28
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Koji-extracted beverage fermented with Pediococcus pentosaceus LP28Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Koji-extracted beverage | Placebo comparator | 100ml/day for 12 weeks Receives: Dietary Supplement: Placebo |
| Koji-extracted beverage fermented with LP28 | Experimental | 100ml/day for 12 weeks. 1x10^11 cells (LP28)/day Receives: Dietary Supplement: Koji-extracted beverage fermented with Pediococcus pentosaceus LP28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI from baseline
Measured: Every 4 weeks (Overall 12 weeks)
Change in body fat mass (percentage) from baseline
Measured: Every 4 weeks (Overall 12 weeks)
Secondary outcomes (10)
Change in abdominal circumference from baseline
Measured: Every 4 weeks (Overall 12 weeks)
Change in visceral fat area by CT scan from baseline
Measured: Weeks 0 and 12
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Measured: Weeks 0 and 12
Change in fasting plasma glucose from baseline
Measured: Every 4 weeks (Overall 12 weeks)
Change in serum triglyceride from baseline
Measured: Every 4 weeks (Overall 12 weeks)
Change in serum total cholesterol from baseline
Measured: Every 4 weeks (Overall 12 weeks)
Change in serum LDL cholesterol from baseline
Measured: Every 4 weeks (Overall 12 weeks)
Change in serum HDL cholesterol from baseline
Measured: Every 4 weeks (Overall 12 weeks)
Change in fasting insulin from baseline
Measured: 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
Measured: Weeks 0 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- Marukome Co., Ltd.
- Responsible party
- Principal investigator, Fumiko Higashikawa, Hiroshima University
- Investigators
- Fumiko Higashikawa, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050555
- Sponsor's protocol ID
- eki-867
- Status last verified
- Aug 2014
- First submitted
- 29 Jan 2014
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
- ClinicalTrials.gov ID
- NCT02050555
- Acronym / sponsor ID
- eki-867
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- Marukome Co., Ltd.
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Koji-extracted beverage | Placebo comparator | Dietary Supplement: Placebo100ml/day for 12 weeks |
| Koji-extracted beverage fermented with LP28 | Experimental | Dietary Supplement: Koji-extracted beverage fermented with Pediococcus pentosaceus LP28100ml/day for 12 weeks. 1x10^11 cells (LP28)/day |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 25-30 kg/m2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Dietary supplement | Koji-extracted beverage |
| Koji-extracted beverage fermented with Pediococcus pentosaceus LP28 | Dietary supplement | Koji-extracted beverage fermented with LP28 |
Primary outcome
Change in BMI from baseline
Time frame: Every 4 weeks (Overall 12 weeks)
Change in body fat mass (percentage) from baseline
Time frame: Every 4 weeks (Overall 12 weeks)
10 secondary outcomes
Change in abdominal circumference from baseline
Time frame: Every 4 weeks (Overall 12 weeks)
Change in visceral fat area by CT scan from baseline
Time frame: Weeks 0 and 12
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
Time frame: Weeks 0 and 12
Change in fasting plasma glucose from baseline
Time frame: Every 4 weeks (Overall 12 weeks)
Change in serum triglyceride from baseline
Time frame: Every 4 weeks (Overall 12 weeks)
Change in serum total cholesterol from baseline
Time frame: Every 4 weeks (Overall 12 weeks)
Change in serum LDL cholesterol from baseline
Time frame: Every 4 weeks (Overall 12 weeks)
Change in serum HDL cholesterol from baseline
Time frame: Every 4 weeks (Overall 12 weeks)
Change in fasting insulin from baseline
Time frame: Weeks 0 and 12
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
Time frame: Weeks 0 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fumiko Higashikawa, PhD principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Koji-extracted beverage fermented with Pediococcus pentosaceus LP28 in people with Overweight, run by Hiroshima University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI from baseline (time frame: Every 4 weeks (Overall 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.