BK329 and Body Fat Reduction

Pusan National University Yangsan Hospital

Status

Completed

Conditions

Obesity and Overweight

Treatments

Dietary Supplement: BK329

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06628791

12-2023-002

Details and patient eligibility

About

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?

Full 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.

Enrollment

100 patients

Sex

All

Ages

19 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.