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Completed

NCT Number: NCT06628791

BK329 and Body Fat Reduction

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?

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Key information

Conditions

Obesity and Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BK329

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo 400 mg/day for 12 weeks

Primary outcomes

  1. Total body fat (kg)

    Time frame: 12 weeks

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

Secondary outcomes

  1. Body fat percentage

    Time frame: 12 weeks

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

  2. Lean body mass (kg)

    Time frame: 12 weeks

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

  3. Body mass index (kg/m2)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  4. Body weight (kg)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  5. Waist-to-hip ratio

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  6. Total cholesterol level (mg/dl)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  7. Triglycerides level (mg/dL)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  8. High-density lipoprotein cholesterol levels (mg/dL)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  9. Low-density lipoprotein cholesterol levels (mg/dL)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  10. Free fatty acid level (mg/dL)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  11. High-sensitivity C-reactive protein (mg/dL)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  12. Total immunoglobulin E level (IU/mL)

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

  13. Neutrophil-to-lymphocyte ratio

    Time frame: 12 weeks

    Measured at baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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