None listed
Conditions
Interventions
Dietary Supplement : Subjects take test food(500 mg/day as immature green persimmon extract) or placebo food twice a day, each time 2 tablets for 12 weeks
Sponsors
Jeju Technopark
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female between 19~60 years 2) BMI gater than 25.0 kg/m2 and less than 30.0 kg/m2 3) Subject who voluntarily decided to paricipate in this clinical trial and signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) Subject who have a history of hypersensitivity or allergies to test food and test food-based medicines. 2) Subject who currently undergoing treatment for serous cardiovascular, respiratory, hepatobiliary, renal and urinary, neurological, musculoskeletal, psychiatric, infectious or malignant disease or conditions. 3) Subject who participated in another clinical trial within 3 months of screening or plans to participate in another clinical trial after the start of this clinical trial. 4) Subject who use of medications that affect weight within 3 months of screening, including obesity medications (appetite suppreseeants, lipoattractants, GLP-1 receptor aonists, etc.), psychiatric medications such as depression and schizophrenia, contraceptives, steroidal agents, female hormonal agents, calcrium, vitamin D, dietary supplements/supplements for weight control, herbal medicines and weight control preparations. 5) Subject who participation in a therapeutic, commercial obesity program aimed at reducing body fat and losing weight within 3 months of screening 6) Subject who had a weight change of 10 % or more within 3 months of screening 7) Subject who had a gastroplasty, bowel resection or other surgical procedure for weight loss within 6 months of screening 8) Subject who initiated newly beta-blockers, diuretics within 6 months of screening or anticipated dose change during the study (but may paricipate if initiated prior to 6 months without dose change) 9) Subject who diabetics with fasting blood glucose > 126 mg/dl or taking antidiabetic medications (oral hypoglycemic agents, insulin, etc.) 10) Subject who TSH less than or equal to 0.1 µU/mL or greater than 10 µU/mL 11) Subject who individuals with severe gastrointestinal disorders that prevent them from consuming test(placebo) food. 12) Subject who have a history of serious psychiatric illness (schizophrenia, epilepsy, anorexia, bulimia, etc.) or alcohol and other substance abuse 13) Subject who with a musculoskeletal condition that would prevnet them from exercising 14) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg) 15) Subject with ALT(GPT) or AST(GOT) greater than or equal to 3 times the upper limit of normal for the site 16) Subject with renal disease or serum creatinine > 2.0 mg/dL 17) Subject who diagnosis of malignancy within 5 years of screening 18) Subject who pregnant, nursing mothers or planning to become pregnant during the duration of this clincial trial 19) Subject who in the opinion of the principal investigator are unable to comply with the protocol or are clinically unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat percentage(%) using DEXA | — |
Secondary
| Measure | Time frame |
|---|---|
| Body fat mass(g), lean body mass(g) using DEXA;Visceral fat atea(cm2), subcutaneous fat area(cm2), total abdominal fat area(cm2) and visceral fat/subcutaneous fat ratio (VSR) using CT;Body weight, Body Mass Index(BMI);waist(cm), hip(cm) and waist/hip ratio;Total Cholesterol, Triglyceride, HDL-Cholesterol, LDL-Cholesterol;Leptin, Adiponectin | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunKyung Sung
Semyung University Oriental Medicine Hospital
Outcome results
None listed