None listed
Conditions
Interventions
Others : At the screening visit (Visit 1), written informed consent will be obtained from each participant after providing a full explanation of the study. Screening assessments will then be performed
Sponsors
Luxbiome Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 years or older and younger than 60 years. 2) Individuals with a body mass index (BMI) of 25.0–29.9 kg/m² (overweight) who are not taking any medications related to body weight or body fat management. 3) Individuals who voluntarily provide written informed consent to participate in this study and are able to understand and comply with the study procedures and requirements.
Exclusion criteria
Exclusion criteria: 1) Individuals who have experienced a weight gain or loss of 5 kg or more within the past 3 months. 2) Individuals who have undergone surgery within the past 6 months or bariatric surgery within the past 1 year. 3) Individuals with clinically significant diseases that may interfere with participation in the study. 4) Individuals who are pregnant or breastfeeding, planning to become pregnant during the study period, or unwilling to use an acceptable method of contraception during the study period. 5) Women who have given birth within the past 6 months. 6) Individuals with a history of drug abuse or those who have taken medications that may affect the study outcomes within the past 1 month. 7) Individuals who have been on a continuous diet regimen within the past year or have participated in a weight reduction program within the past 3 months. 8) Individuals who have received subcutaneous injections for weight management within the past year. 9) Individuals with known allergies or adverse reactions to any ingredients contained in the test product or control product. 10) Individuals who consume excessive amounts of alcohol or are heavy smokers. 11) Individuals who have consumed products containing the same or similar ingredients as the test product within the past 1 month. 12) Individuals who have taken medications (including anti-obesity drugs) or health functional foods related to body fat reduction within the past 3 months. 13) Individuals who have participated in another human study or clinical trial within the past 3 months, or who plan to participate during the study period. 14) Individuals deemed unsuitable for participation in the study by the Principal Investigator based on clinical laboratory test results or other relevant reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total body fat mass | — |
Secondary
| Measure | Time frame |
|---|---|
| Body fat mass by body part;body fat percentage;lean mass;Total abdominal fat area, visceral fat area, subcutaneous fat area, and visceral-to-subcutaneous fat area ratio;anthropometric measurements;Lipid-related indicator;Metabolic and appetite-regulating hormones;Muscle-related biomarkers;Adverse Event;Vital Signs;Physical examination | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun Jin Choi
Bestian Seoul Hospital
Outcome results
None listed