ObesityNCT01685944
Anti-Obesity Effect of Pediococcus Pentosaceus LP28
A study testing Live Pediococcus pentosaceus LP28 and Heat-killed Pediococcus pentosaceus LP28 in people with Obesity, run by Hiroshima University at 1 site in Japan.
Trial summary
This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Live Pediococcus pentosaceus LP28 and Heat-killed Pediococcus pentosaceus LP28
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2012to Apr 2013
- 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 medicines 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity
This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2.
- Conditions
- Obesity
- Being tested
- Live Pediococcus pentosaceus LP28, Heat-killed Pediococcus pentosaceus LP28, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Pediococcus pentosaceus LP28Dietary supplement
Heat-killed Pediococcus pentosaceus LP28Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Live Pediococcus pentosaceus LP28 | Experimental | Not described Receives: Dietary Supplement: Live Pediococcus pentosaceus LP28 |
| Heat-killed Pediococcus pentosaceus LP28 | Experimental | Not described Receives: Dietary Supplement: Heat-killed Pediococcus pentosaceus LP28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat
Measured: Every 4 weeks (Overall 12 weeks)
BMI
Body weight will be measured every morning.
Measured: Every day (Overall 14 weeks)
Secondary outcomes (11)
Abdominal circumference
Measured: Every 4 weeks (Overall 12 weeks)
Serum triglyceride
Measured: Every 4 weeks (Overall 12 weeks)
Total cholesterol
Measured: Every 4 weeks (Overall 12 weeks)
LDL cholesterol
Measured: Every 4 weeks (Overall 12 weeks)
HDL cholesterol
Measured: Every 4 weeks (Overall 12 weeks)
Fasting blood glucose
Measured: Every 4 weeks (Overall 12 weeks)
Fasting insulin
Measured: Weeks 0 and 12
HOMA-R
Measured: Weeks 0 and 12
Adiponectin
Measured: Weeks 0 and 12
Leptin
Measured: Weeks 0 and 12
Resistin
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 posted14 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fumiko Higashikawa, Hiroshima University
- Investigators
- Fumiko Higashikawa, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685944
- Sponsor's protocol ID
- eki-619
- Status last verified
- Feb 2016
- First submitted
- 12 Sep 2012
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity
- ClinicalTrials.gov ID
- NCT01685944
- Acronym / sponsor ID
- eki-619
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 14 Sep 2012 (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 efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Live Pediococcus pentosaceus LP28 | Experimental | Dietary Supplement: Live Pediococcus pentosaceus LP28 |
| Heat-killed Pediococcus pentosaceus LP28 | Experimental | Dietary Supplement: Heat-killed Pediococcus pentosaceus LP28 |
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 (5 listed)
- Taking medicines 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 |
|---|---|---|
| Live Pediococcus pentosaceus LP28 | Dietary supplement | Live Pediococcus pentosaceus LP28 |
| Heat-killed Pediococcus pentosaceus LP28 | Dietary supplement | Heat-killed Pediococcus pentosaceus LP28 |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Body fat
Time frame: Every 4 weeks (Overall 12 weeks)
BMI
Time frame: Every day (Overall 14 weeks)
Body weight will be measured every morning.
11 secondary outcomes
Abdominal circumference
Time frame: Every 4 weeks (Overall 12 weeks)
Serum triglyceride
Time frame: Every 4 weeks (Overall 12 weeks)
Total cholesterol
Time frame: Every 4 weeks (Overall 12 weeks)
LDL cholesterol
Time frame: Every 4 weeks (Overall 12 weeks)
HDL cholesterol
Time frame: Every 4 weeks (Overall 12 weeks)
Fasting blood glucose
Time frame: Every 4 weeks (Overall 12 weeks)
Fasting insulin
Time frame: Weeks 0 and 12
HOMA-R
Time frame: Weeks 0 and 12
Adiponectin
Time frame: Weeks 0 and 12
Leptin
Time frame: Weeks 0 and 12
Resistin
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 26 Feb 2016.
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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 Live Pediococcus pentosaceus LP28 and Heat-killed Pediococcus pentosaceus LP28 in people with Obesity, 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 5 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 26 Feb 2016. 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?
Body fat (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 26 Feb 2016.