None listed
Conditions
Interventions
Dietary Supplement : Test Product: capsule that contains the CKDB-322
Comparator Product: matching placebo
Sponsors
Chong Kun Dang Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Individuals who have voluntarily given written informed consent after receiving adequate information about this trial. 2. Adults, both male and female, aged between 19 and 65 years as of the date of written consent. 3. Individuals with a Body Mass Index (BMI) of 25 kg/m² to less than 30 kg/m². 4. Individuals with a waist circumference of more than 90 cm for men and more than 85 cm for women.
Exclusion criteria
Exclusion criteria: - Pregnant or lactating women. - Women of childbearing potential and men who are unwilling or unable to use appropriate contraception methods during the trial. - Women who have given birth within the last 6 months prior to screening. - Individuals with the following conditions or medical history: Uncontrolled hypertension, diabetes, Neurological or endocrine disorders affecting body weight, Severe mental illness, alcohol abuse, malignant tumors, Severe cerebrovascular, Individuals with severe concomitant diseases/disabilities deemed unsuitable for participation by the investigator etc. - Individuals administered the following drugs and food: Anti-obesity drugs or significant weight-changing medication etc. - Hypersensitivity to any component of the study food or other allergies deemed unsuitable for participation by the investigator. - Weight change of more than 5% within the past month. - Participation in another study involving clinical trial drugs, foods, or medical devices within the past 3 months. - Any other reasons deemed by the investigator as inappropriate for conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body fat mass measured by DEXA at 12 weeks post-consumption of the study food, compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body fat percentage measured by DEXA at 12 weeks post-consumption of the study food, compared to baseline.;Change in total abdominal fat area, visceral fat area, subcutaneous fat area measured by CT at 12 weeks post-consumption of the study food, compared to baseline.;Change in body weight at 6 and 12 weeks post-consumption of the study food, compared to baseline.;Change in cytokine levels (Adiponectin, Leptin) at 12 weeks post-consumption of the study food, compared to baseline. | — |
Countries
Korea, Republic of
Contacts
Public ContactSoojung Park
Woosuk University Korean Medicine Medical Center
Outcome results
None listed