ObesityNCT03248414
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
A study testing Lactobacillus sakei in people with Obesity, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Lactobacillus sakei
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2016to 10 Sep 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 20-65 years
- BMI equal to higher than 25 kg/m2
Who cannot join
- under anti-obesity medication
- uncontrolled diabetes
- uncontrolled hypertension
- any medications can influence to body weight such as thiazolidinedione, GLP-1 analogue, SGLT2 inhibitor, diuretics
- thyroid function test abnormality
- malignancy within 5 years
Show all 9Show fewer
- immune compromised hosts or under immune suppressants
- antibiotics or probiotics withing 2 weeks
- any intervention to reduce body weight within 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.
Read the detailed description
We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.
- Conditions
- Obesity
- Being tested
- Lactobacillus sakei
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus sakeiDietary supplement
1 pack contained 5 x 109 cfu
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus sakei | Experimental | 2 packs per day Receives: Dietary Supplement: Lactobacillus sakei |
| Control | Placebo comparator | 2 packs per day Receives: Dietary Supplement: Lactobacillus sakei |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass change in 12-week
fat mass is measured by DEXA
Measured: 12 weeks
Secondary outcomes (6)
Changes in body weight
body weight change
Measured: 12 weeks
Changes in waist circumference
Waist circumference change
Measured: 12 weeks
Glucose metabolism
Changes in HbA1c
Measured: 12 weeks
Glucose metabolism
Changes in fasting glucose concentration
Measured: 12 weeks
Glucose metabolism
Changes in insulin resistance
Measured: 12 weeks
Glucose metabolism
Changes in beta-cell function
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start10 Aug 2016
- Primary completion10 Jun 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248414
- Sponsor's protocol ID
- B-1511/324-002
- Status last verified
- Sep 2018
- First submitted
- 9 Aug 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim S, Moon JH, Shin CM, Jeong D, Kim B. Effect of Lactobacillus sakei, a Probiotic Derived from Kimchi, on Body Fat in Koreans with Obesity: A Randomized Controlled Study. Endocrinol Metab (Seoul). 2020 Jun;35(2):425-434. doi: 10.3803/EnM.2020.35.2.425. Epub 2020 Jun 24.
PubMed 32615727
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
- ClinicalTrials.gov ID
- NCT03248414
- Acronym / sponsor ID
- B-1511/324-002
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 14 Aug 2017 (actual)
- 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.
In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.
Detailed description
We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus sakei | Experimental | Dietary Supplement: Lactobacillus sakei2 packs per day |
| Control | Placebo comparator | Dietary Supplement: Lactobacillus sakei2 packs per day |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 20-65 years
- BMI equal to higher than 25 kg/m2
Key exclusion criteria (9 listed)
- under anti-obesity medication
- uncontrolled diabetes
- uncontrolled hypertension
- any medications can influence to body weight such as thiazolidinedione, GLP-1 analogue, SGLT2 inhibitor, diuretics
- thyroid function test abnormality
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 |
|---|---|---|
| Lactobacillus sakei1 pack contained 5 x 109 cfu | Dietary supplement | Control, Lactobacillus sakei |
Primary outcome
Fat mass change in 12-week
Time frame: 12 weeks
fat mass is measured by DEXA
6 secondary outcomes
Changes in body weight
Time frame: 12 weeks
Changes in waist circumference
Time frame: 12 weeks
Glucose metabolism
Time frame: 12 weeks
Glucose metabolism
Time frame: 12 weeks
Glucose metabolism
Time frame: 12 weeks
Glucose metabolism
Time frame: 12 weeks
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 Sep 2018.
- Derived from this study: PubMed 32615727Lim S, Moon JH, Shin CM, Jeong D, Kim B. Effect of Lactobacillus sakei, a Probiotic Derived from Kimchi, on Body Fat in Koreans with Obesity: A Randomized Controlled Study. Endocrinol Metab (Seoul). 2020 Jun;35(2):425-434. doi: 10.3803/EnM.2020.35.2.425. Epub 2020 Jun 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus sakei in people with Obesity, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 inclusion and 9 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 Sep 2018. 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 South Korea. 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?
Fat mass change in 12-week (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248414, which also lists 1 linked publication.
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 Sep 2018.