Table 1.
Inclusion and exclusion criteriaa
| Criteria |
|---|
| Inclusion criteria |
| 1. Men and women ages 18 to 65 years |
| 2. Individuals who meet one of the following criteria: |
| 2.1. BMI ≥ 30 kg/m2 |
| 2.2. BMI 27 to 30 kg/m2 with hypertension at a proper treatment- and blood pressure-controlled 95 to 145 mmHg |
| 2.3. BMI 27 to 30 kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose < 7.8 mmol/L (140 mg/dl) |
| 2.4. BMI 27 to 30 kg/m2 with hyperlipidaemia in a proper treatment regimen |
| 2.5. BMI 27 to 30 kg/m2 and ≥ 236 mg/dl total cholesterol or ≥ 150 mg/dl triglycerides at screening |
| 3. Agreed to low-calorie diet during the trial |
| 4. Written informed consent for participation in the trial |
| 5. Written informed consent for the genetic test |
| Exclusion criteria |
| 1. Endocrine disease such as hypothyroidism or Cushing syndrome |
| 2. Heart disease (heart failure, angina pectoris and/or myocardial infarction) |
| 3. Uncontrolled hypertension (SBP > 145 mmHg or DBP > 95 mmHg) |
| 4. Malignant tumour or lung disease |
| 5. Cholelithiasis |
| 6. Severe renal disability (sCr > 2.0 mg/dl) |
| 7. Severe liver disability (2.5-fold the normal high range value for ALT, AST and ALP) |
| 8. Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8 mmol/L (140 mg/d or over |
| 9. Narrow-angle glaucoma |
| 10. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia and so on) |
| 11. History of stroke or temporary ischaemic cardioplegia |
| 12. History or existence of eating disorder such as anorexia nervosa or bulimia nervosa |
| 13. Use of medication within the past 3 months that could have an effect on weight (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having an effect on absorption, metabolism and excretion) |
| 14. Use of β-blocker or diuretic as hypertension medication within the past 3 months |
| 15. Use of central nervous system medications or central nervous system stimulating weight reduction medications |
| 16. Forbidden treatments (insulin, hypoglycaemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic and concerns related to medication abuse) |
| 17. Difficult-to-measure anthropometric dimensions due to anatomical changes such as resection surgery |
| 18. History of weight reduction surgery, bariatric surgery and so on |
| 19. Unable to follow instructions during the trial as judged by the investigator |
| 20. Women who are pregnant, lactating, planning a pregnancy or women of child-bearing age who do not agree to proper contraception (birth control pill, hormone implant, IUD, spermicide, condom, abstinence and so on) (women of child-bearing age indicated to be within 2 years of menopause who did not receive hysterectomy, bilateral tubal ligation, bilateral oophorectomy, and so on) |
| 21. Use of other investigational products within the past month |
| 22. Weight reduction > 10% within the past 6 months |
| 23. Cessation of smoking within past 3 months or an irregular smoking habit |
aALP alkaline phosphatase, ALT alanine aminotransferase, ASTaspartate aminotransferase, BMI body mass index, DBP diastolic blood pressure, IUD intrauterine device; SBP systolic blood pressure, sCr, serum creatinine