Metabolic syndrome
Conditions
Interventions
Intake of sudachi peel tablets (5 tablets/day, for 12 weeks)
Intake of placebo tablets (5 tablets/day, for 12 weeks)
Sponsors
Tokushima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Meets [1) or 2)] and [at least one of the followings;3),4),5)] and 6) 1)Waist>=85cm(man), >=90cm(woman) 2)BMI>=25kg/m/m 3)FBS>=100mg/dl or HbA1c>5.2% or treating wiht the medicine 4)Serum triglyceriders>=150mg/dl or treating wiht the medicine 5)Systolic blood pressure>=130mmHg or diastolic blood pressure>=85mmHg or treating wiht the medicine 6)Is from 20 or more to 74 years old or less
Exclusion criteria
Exclusion criteria: 1)Has complications in brain, heart, kidny, lungs, liver(cerbovascular accident, myocardial infraction, angina pectoris, a history of cardiovascular intervention, heart failure, arteriosclerosis obliterans, nephropathy, bronchial asthma, pulmonary emphysema, pneumenitis, pulmonary fibrosis, viral hepatitis, cirrhosis, diabetic complications, diabetes treated with insulin) 2)To whom pharmaceutical agents shold be considered for hypertension, lipid disorder, diabetes mellitus and/or other diseases 3)Has a overt systemic diseases 4)Has a history of malignant diseases 5)Is a participant in other clinical trial 6)Is not appropriate in the investigators' opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Triglyceride Fasting plasma glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)LDL-cholesterol, HDL-cholesterol, RLP-cholesterol, free fatty acid 2)HbA1c, insulin resistance 3)Uric acid 4)hs-CRP, TNF-alfa, adiponectin, urinary 8OH-dG 5)Body weight, BMI, body fat parcentage, waist | — |
Countries
Japan
Contacts
Public ContactChiho Sato
Tokushima University Hospital Crinical Trial Center for Development Therapeutics
Outcome results
None listed