None listed
Conditions
Interventions
Dietary Supplement : Subjects are randomly assigned and divided into test groups and control groups.
In test group, 250mg of NKH-31-11, which is a test food, is taken twice a day and twice a day with
Sponsors
Nova K Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female between 20-65 years 2) BMI=25kg/m^2 and <32kg/m^2 3) Subject who voluntarily agrees to participate and sign in informed consent form
Exclusion criteria
Exclusion criteria: 1) Within the last six months, those with severe cerebrovascular diseases (brain infarction, cerebral hemorrhage, etc.) or heart disease (critic vein that requires care, myocardial infarction, heart failure, and treatment) (however, those who have a history of cerebrovascular disease and heart disease but who are clinically stable may participate in the human testing by the tester's judgment.) 2) In the last one month or less, a person who has been taking drugs (absorbent laxatives and appetite suppressants, health function foods/supplementants related to obesity improvement, psychotropic drugs such as depression, beta-blockers, diuretics, contraceptives, steroids, and female hormones) that affect his or her body weight. 3) Patients with unadjusted high blood pressure (blood pressure is 160/100 mmHg or higher, and the criteria for measurement after 10 minutes of stabilization of the human subjects) 4) Diabetes patients with an empty blood sugar level of 126 mg/dl or more or who are taking oral blood sugar depressants or insulin. 5) Persons with TSH of 0.1 µU/ml or greater than 10 µU/ml 6) A person whose creatine is more than twice the normal limit of the testing agency 7) A person whose AST (GOT) or ALT (GPT) is more than three times the normal upper limit of the testing agency 8) A person who complains of severe gastrointestinal symptoms such as heartburn and indigestion. 9) A person who is hospitalized, treated, and rehabilitated due to alcohol use disorder, heart disease, and central nervous disorder through a medical examination 10) A person who is deemed unable to exercise due to musculoskeletal disease 11) Those who have participated in commercial obesity programs within the last three months; 12) Persons who have participated in or plan to participate in other clinical trials within the last 1 month; 13) A person or breastfeeding woman who is pregnant or has plans for pregnancy during this human testing period. 14) A person who believes that the tester is unfit for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat rate, body fat amount by DEXA(Dual-energy X-ray absorptiometry) | — |
Secondary
| Measure | Time frame |
|---|---|
| weight;Waist Circumference, Hip Circumferenc, Waist to Hip Ratio;Body Mass Index(BMI);Lean Mass by DEXA(Dual-energy X-ray absorptiometry);Visceral Fat Area, Subcutaneous Fat Area, Taoal Fat Area,Visceral fat / Subcutanesou Fat Ratio by CT;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;Adiponectin, hs-CRP, Leptin;adverse events;Vital Sign(pulsus, arteriotony);clinical laboratory test(hematologic/chemistry examination, Urinalysis);electrocardiography | — |
Countries
Korea, Republic of
Contacts
Public ContactByeong Han
Sahmyook Medical Center
Outcome results
None listed