BK329 and Body Fat Reduction | NCT06628791

Studies
BK329 and Body Fat Reduction

NCT06628791

Sponsor

Pusan National University Yangsan Hospital

Status

Completed

Last Update Posted

Jan 6, 2026Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Obesity and Overweight

Interventions

BK329
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2024Actual

Primary Completion Date

Jul 8, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Oct 4, 2024

First Submission Date that Met QC Criteria

Oct 4, 2024

First Posted Date

Oct 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2025

Last Update Posted Date

Jan 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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?

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BK329 group	Experimental	This group takes BK329 for 12 weeks.	Dietary Supplement: BK329
Placebo group	Placebo Comparator	This group takes placebo for 12 weeks.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BK329	Dietary Supplement	Lactococcus lactics. subsp. lactis CAB701(KCCM13360P) 400 mg/day for 12 weeks	BK329 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total body fat (kg)	Using dual-energy X-ray absorptiometry at baseline and 12 weeks	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Body fat percentage	Using dual-energy X-ray absorptiometry at baseline and 12 weeks	12 weeks
Lean body mass (kg)	Using dual-energy X-ray absorptiometry at baseline and 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

individuals with a Body Mass Index (BMI) between 23 and 30 kg/m2.
Individuals who have provided written consent on the consent form.

Exclusion Criteria:

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.
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D009765	Obesity
D050177	Overweight