BK329 and Body Fat Reduction

NCT ID: NCT06628791

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-26
• Study Completion Date: 2024-12-31

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.

Conditions

Obesity and Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

BK329 group

This group takes BK329 for 12 weeks.

Group Type: EXPERIMENTAL

BK329

Intervention Type: DIETARY_SUPPLEMENT

Lactococcus lactics. subsp. lactis CAB701(KCCM13360P) 400 mg/day for 12 weeks

Placebo group

This group takes placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo 400 mg/day for 12 weeks

Interventions

BK329

Lactococcus lactics. subsp. lactis CAB701(KCCM13360P) 400 mg/day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo 400 mg/day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Yeoup Lee

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Yeoup Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Countries

South Korea

Other Identifiers

12-2023-002

Identifier Type: -

Identifier Source: org_study_id