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?

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.

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.