Obesity and OverweightNCT06628791
BK329 and Body Fat Reduction
A study testing BK329 in people with Obesity and Overweight, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
This clinical trial aims to determine whether BK329 reduces body fat in adults with overweight or obesity and to assess its safety. The main questions are: Does BK329 reduce body fat in participants? What side effects occur when participants take BK329? Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- BK329
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jan 2024to 31 Dec 2024
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals with a Body Mass Index (BMI) between 23 and 30 kg/m2.
- Individuals who have provided written consent on the consent form.
Who cannot join
- Subjects with severe cerebrovascular disease (e.g., stroke, cerebral hemorrhage), heart disease (e.g., angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumors within the last 6 months. (However, subjects with a history of these diseases who are clinically stable may participate at the investigator's discretion.)
- Uncontrolled hypertensive patients (blood pressure ≥160/100mmHg, measured after 10 minutes of rest).
- Diabetic patients with poor blood glucose control (fasting glucose ≥160mg/dL).
- Subjects undergoing treatment for hypothyroidism or hyperthyroidism.
- Subjects with creatinine levels ≥ 2 times the upper limit of the research institution's normal range.
- Subjects with aspartate transaminase or alanine transaminase levels ≥ 3 times the upper limit of the research institution's normal range.
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- Subjects experiencing severe gastrointestinal symptoms such as heartburn or indigestion (lactose intolerance).
- Subjects who have taken weight-altering drugs (absorption inhibitors, appetite suppressants, obesity-related supplements, psychiatric drugs, beta-blockers, diuretics, contraceptives, steroids, or female hormones) within the last month.
- Subjects who have participated in commercial weight loss programs within the last 3 months.
- Subjects who have participated in or plan to participate in another clinical trial within the last month.
- Alcohol abusers.
- Subjects who quit smoking within the last 3 months.
- Pregnant or breastfeeding women or those planning pregnancy during the trial period.
- Subjects with allergies to any components of the study foods.
- Subjects deemed inappropriate for the study by the investigator for other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: Effects of Oral Intake of BK329 on Body Fat Reduction in Adults With Overweight or Obesity: a Randomized, Double-blind, Placebo-controlled Clinical Trial
This clinical trial aims to determine whether BK329 reduces body fat in adults with overweight or obesity and to assess its safety.
The main questions are:
- Does BK329 reduce body fat in participants?
- What side effects occur when participants take BK329?
Read the detailed description
Researchers will compare BK329 to a placebo to evaluate its effectiveness in reducing body fat.
Participants will:
- Take BK329 or a placebo daily for 12 weeks.
- Visit the clinic every six weeks for checkups and tests.
- Conditions
- Obesity and Overweight
- Being tested
- BK329, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BK329Dietary supplement
Lactococcus lactics. subsp. lactis CAB701(KCCM13360P) 400 mg/day for 12 weeks
PlaceboDietary supplement
Placebo 400 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| BK329 group | Experimental | This group takes BK329 for 12 weeks. Receives: Dietary Supplement: BK329 |
| Placebo group | Placebo comparator | This group takes placebo for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body fat (kg)
Using dual-energy X-ray absorptiometry at baseline and 12 weeks
Measured: 12 weeks
Secondary outcomes (13)
Body fat percentage
Using dual-energy X-ray absorptiometry at baseline and 12 weeks
Measured: 12 weeks
Lean body mass (kg)
Using dual-energy X-ray absorptiometry at baseline and 12 weeks
Measured: 12 weeks
Body mass index (kg/m2)
Measured at baseline and 12 weeks
Measured: 12 weeks
Body weight (kg)
Measured at baseline and 12 weeks
Measured: 12 weeks
Waist-to-hip ratio
Measured at baseline and 12 weeks
Measured: 12 weeks
Total cholesterol level (mg/dl)
Measured at baseline and 12 weeks
Measured: 12 weeks
Triglycerides level (mg/dL)
Measured at baseline and 12 weeks
Measured: 12 weeks
High-density lipoprotein cholesterol levels (mg/dL)
Measured at baseline and 12 weeks
Measured: 12 weeks
Low-density lipoprotein cholesterol levels (mg/dL)
Measured at baseline and 12 weeks
Measured: 12 weeks
Free fatty acid level (mg/dL)
Measured at baseline and 12 weeks
Measured: 12 weeks
High-sensitivity C-reactive protein (mg/dL)
Measured at baseline and 12 weeks
Measured: 12 weeks
Total immunoglobulin E level (IU/mL)
Measured at baseline and 12 weeks
Measured: 12 weeks
Neutrophil-to-lymphocyte ratio
Measured at baseline and 12 weeks
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 posted8 Oct 2024
- Study start26 Jan 2024
- Primary completion8 Jul 2024
- Study completion31 Dec 2024
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 Obesity and 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628791
- Sponsor's protocol ID
- 12-2023-002
- Status last verified
- Dec 2025
- First submitted
- 4 Oct 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi JI, Lee YL, Lee SY. Lactococcus Lactis Subsp. Lactis CAB701 Reduces Body fat mass in Adults with Overweight or Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial. Probiotics Antimicrob Proteins. 2026 Sep 2. doi: 10.1007/s12602-026-11198-1. Online ahead of print.
PubMed 42684653
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Intake of BK329 on Body Fat Reduction in Adults With Overweight or Obesity: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06628791
- Acronym / sponsor ID
- 12-2023-002
- Conditions
- Obesity and Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Oct 2024 (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.
This clinical trial aims to determine whether BK329 reduces body fat in adults with overweight or obesity and to assess its safety.
The main questions are:
- Does BK329 reduce body fat in participants?
- What side effects occur when participants take BK329?
Detailed description
Researchers will compare BK329 to a placebo to evaluate its effectiveness in reducing body fat.
Participants will:
- Take BK329 or a placebo daily for 12 weeks.
- Visit the clinic every six weeks for checkups and tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BK329 group | Experimental | Dietary Supplement: BK329This group takes BK329 for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThis group takes placebo for 12 weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- individuals with a Body Mass Index (BMI) between 23 and 30 kg/m2.
- Individuals who have provided written consent on the consent form.
Key exclusion criteria (15 listed)
- Subjects with severe cerebrovascular disease (e.g., stroke, cerebral hemorrhage), heart disease (e.g., angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumors within the last 6 months. (However, subjects with a history of these diseases who are clinically stable may participate at the investigator's discretion.)
- Uncontrolled hypertensive patients (blood pressure ≥160/100mmHg, measured after 10 minutes of rest).
- Diabetic patients with poor blood glucose control (fasting glucose ≥160mg/dL).
- Subjects undergoing treatment for hypothyroidism or hyperthyroidism.
- Subjects with creatinine levels ≥ 2 times the upper limit of the research institution's normal range.
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 |
|---|---|---|
| BK329Lactococcus lactics. subsp. lactis CAB701(KCCM13360P) 400 mg/day for 12 weeks | Dietary supplement | BK329 group |
| PlaceboPlacebo 400 mg/day for 12 weeks | Dietary supplement | Placebo group |
Primary outcome
Total body fat (kg)
Time frame: 12 weeks
Using dual-energy X-ray absorptiometry at baseline and 12 weeks
13 secondary outcomes
Body fat percentage
Time frame: 12 weeks
Lean body mass (kg)
Time frame: 12 weeks
Body mass index (kg/m2)
Time frame: 12 weeks
Body weight (kg)
Time frame: 12 weeks
Waist-to-hip ratio
Time frame: 12 weeks
Total cholesterol level (mg/dl)
Time frame: 12 weeks
Triglycerides level (mg/dL)
Time frame: 12 weeks
High-density lipoprotein cholesterol levels (mg/dL)
Time frame: 12 weeks
Low-density lipoprotein cholesterol levels (mg/dL)
Time frame: 12 weeks
Free fatty acid level (mg/dL)
Time frame: 12 weeks
High-sensitivity C-reactive protein (mg/dL)
Time frame: 12 weeks
Total immunoglobulin E level (IU/mL)
Time frame: 12 weeks
Neutrophil-to-lymphocyte ratio
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 6 Jan 2026.
- Derived from this study: PubMed 42684653Choi JI, Lee YL, Lee SY. Lactococcus Lactis Subsp. Lactis CAB701 Reduces Body fat mass in Adults with Overweight or Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial. Probiotics Antimicrob Proteins. 2026 Sep 2. doi: 10.1007/s12602-026-11198-1. Online ahead of print.
- 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.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BK329 in people with Obesity and Overweight, run by Pusan National University Yangsan 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 15 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 6 Jan 2026. 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?
Total body fat (kg) (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 NCT06628791, 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 6 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.