BK329 and Body Fat Reduction

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?

Study Overview

• Status: Completed
• Conditions: Obesity and Overweight
• Intervention / Treatment: Dietary supplement: BK329; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Yangsan, South Korea, 50612
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; This group takes placebo for 12 weeks.	Dietary supplement: Placebo; Placebo 400 mg/day for 12 weeks
Experimental: BK329 group; This group takes BK329 for 12 weeks.	Dietary supplement: BK329; Lactococcus lactics. subsp. lactis CAB701(KCCM13360P) 400 mg/day for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	12 weeks
Body mass index (kg/m2)	Measured at baseline and 12 weeks	12 weeks
Body weight (kg)	Measured at baseline and 12 weeks	12 weeks
Waist-to-hip ratio	Measured at baseline and 12 weeks	12 weeks
Total cholesterol level (mg/dl)	Measured at baseline and 12 weeks	12 weeks
Triglycerides level (mg/dL)	Measured at baseline and 12 weeks	12 weeks
High-density lipoprotein cholesterol levels (mg/dL)	Measured at baseline and 12 weeks	12 weeks
Low-density lipoprotein cholesterol levels (mg/dL)	Measured at baseline and 12 weeks	12 weeks
Free fatty acid level (mg/dL)	Measured at baseline and 12 weeks	12 weeks
High-sensitivity C-reactive protein (mg/dL)	Measured at baseline and 12 weeks	12 weeks
Total immunoglobulin E level (IU/mL)	Measured at baseline and 12 weeks	12 weeks
Neutrophil-to-lymphocyte ratio	Measured at baseline and 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Actual): July 8, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 12-2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No