NCT06628791

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

October 4, 2024

Last Update Submit

December 31, 2025

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

  • Total body fat (kg)

    Using dual-energy X-ray absorptiometry at baseline and 12 weeks

    12 weeks

Secondary Outcomes (13)

  • Body fat percentage

    12 weeks

  • Lean body mass (kg)

    12 weeks

  • Body mass index (kg/m2)

    12 weeks

  • Body weight (kg)

    12 weeks

  • Waist-to-hip ratio

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

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

BK329DIETARY_SUPPLEMENT

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

BK329 group
PlaceboDIETARY_SUPPLEMENT

Placebo 400 mg/day for 12 weeks

Placebo group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sang Yeoup Lee, MD, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

January 26, 2024

Primary Completion

July 8, 2024

Study Completion

December 31, 2024

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)