Clinical trial NCT06628791: BK329 and Body Fat Reduction
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity and Overweight
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total body fat (kg)
timeFrame: 12 weeks
Secondary outcomes:
measure: Body fat percentage
timeFrame: 12 weeks
measure: Lean body mass (kg)
timeFrame: 12 weeks
measure: Body mass index (kg/m2)
timeFrame: 12 weeks
measure: Body weight (kg)
timeFrame: 12 weeks
measure: Waist-to-hip ratio
timeFrame: 12 weeks
measure: Total cholesterol level (mg/dl)
timeFrame: 12 weeks
measure: Triglycerides level (mg/dL)
timeFrame: 12 weeks
measure: High-density lipoprotein cholesterol levels (mg/dL)
timeFrame: 12 weeks
measure: Low-density lipoprotein cholesterol levels (mg/dL)
timeFrame: 12 weeks
measure: Free fatty acid level (mg/dL)
timeFrame: 12 weeks
measure: High-sensitivity C-reactive protein (mg/dL)
timeFrame: 12 weeks
measure: Total immunoglobulin E level (IU/mL)
timeFrame: 12 weeks
measure: Neutrophil-to-lymphocyte ratio
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: