BK329 and Body Fat Reduction
- Conditions
- Obesity and Overweight
- Interventions
- Dietary Supplement: BK329Dietary Supplement: Placebo
- Registration Number
- NCT06628791
- Lead Sponsor
- Pusan National University Yangsan Hospital
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- individuals with a Body Mass Index (BMI) between 23 and 30 kg/m2.
- Individuals who have provided written consent on the consent form.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BK329 group BK329 This group takes BK329 for 12 weeks. Placebo group Placebo This group takes placebo for 12 weeks.
- Primary Outcome Measures
Name Time Method Total body fat (kg) 12 weeks Using dual-energy X-ray absorptiometry at baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Body fat percentage 12 weeks Using dual-energy X-ray absorptiometry at baseline and 12 weeks
Lean body mass (kg) 12 weeks Using dual-energy X-ray absorptiometry at baseline and 12 weeks
Body mass index (kg/m2) 12 weeks Measured at baseline and 12 weeks
Body weight (kg) 12 weeks Measured at baseline and 12 weeks
Waist-to-hip ratio 12 weeks Measured at baseline and 12 weeks
Total cholesterol level (mg/dl) 12 weeks Measured at baseline and 12 weeks
Triglycerides level (mg/dL) 12 weeks Measured at baseline and 12 weeks
High-density lipoprotein cholesterol levels (mg/dL) 12 weeks Measured at baseline and 12 weeks
Low-density lipoprotein cholesterol levels (mg/dL) 12 weeks Measured at baseline and 12 weeks
Free fatty acid level (mg/dL) 12 weeks Measured at baseline and 12 weeks
High-sensitivity C-reactive protein (mg/dL) 12 weeks Measured at baseline and 12 weeks
Total immunoglobulin E level (IU/mL) 12 weeks Measured at baseline and 12 weeks
Neutrophil-to-lymphocyte ratio 12 weeks Measured at baseline and 12 weeks
Trial Locations
- Locations (1)
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of