None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly assigned to receive GM-T(Triticum aestivum L. extract) 1200mg or placebo.
Subjets will take orally self-administer GM-T(Triticum aestivum L. extract) 120
Sponsors
GeneMatrix
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial. ? Male and female subjects between 20-60years of age inclusive ? BMI of 25.0-29.9kg/m2
Exclusion criteria
Exclusion criteria: 1)The Patients with severe cerebrovascular disease(infarct, hemorrage), cardiac disease(angina, myocardiac infarct, heart failure, arrhythmias that require treatment) within recent 6 months. (If that patient's clinical status is stable, they can participate in the clinical trial according to investgator) 2)Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg. 3)Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL. 4)TSH(Thyroid Stimulating Hormone) value =0.1uU/ml or =10 uU/ml 5)Serum creatinine = 2 times the upper limit of normal. 6)Serum AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase) = 3 times the upper limit of normal. 7)Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia 8)The patient who take the medicine that can affect the state of weight change (uptake inhibitors, appetite suppressant, antiobesity-related health functional food / supplements, antipsychotics, beta blocker, hydragogue, contraceptives, steroid, and hormon)within recent 1 months. 9)Participation in commercial diet program within the 3 months prior to screening. 10)Participation in any clinical trial within the 1 months prior to screening. 11)Subjects who get hospitalization, medications or rehabilitation treatments for Alcohol disorders, cardiovascular disease, disorder of central nervous system. 12)Subjects with the musculoskeletal disorders or restricted physical activity. 13)Pregnant or possibility of pregnancy, or breast feeding mothers. 14)Allergy or hypersensitivity in the GM-T(Triticum aestivum L. extract) 15)Inappropriate person decided by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chainge in fat percentage(by Dual Energy X-Ray Absorptiometry, DEXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight , Body mass index(BMI);Waist circumference, Hip circumference, waist-hip ratio(WHR);Fat mass, Fat Free Mass(by Dual Energy X-Ray Absorptiometry, DEXA) ;Mesenteric fat area, Subcutaneous fat area, Total abdominal fat area, Mesenteric fat area/Subcutaneous fat area(by CT);Blood Lipid;Adiponectin, Leptin, hs-CRP;Adverse Event;Blood pressure, Pulse;Electrocardiography;Clinical pathology examination | — |
Countries
Korea, Republic of
Contacts
Public ContactHyeyoung Kang
Inje University Seoul Paik Hospital
Outcome results
None listed