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Table 1 Inclusion and exclusion criteria

From: Effect of a herbal extract powder (YY-312) from Imperata cylindrica Beauvois, Citrus unshiu Markovich, and Evodia officinalis Dode on body fat mass in overweight adults: a 12-week, randomized, double-blind, placebo-controlled, parallel-group clinical trial

Inclusion Criteria

 Age: 19–60 years

 Body mass index: 25.0–29.9 kg/m2

 Signed written informed consent

Exclusion Criteria

 Blood pressure ≥ 160/100 mmHg or treated with diuretics or β-blockers

 Fasting plasma glucose ≥126 mg/dL or treated with oral hypoglycemic agents or insulin

 Fasting serum triglyceride level > 600 mg/dL

 Serum AST or ALT level ≥ 3 times the upper limit of normal

 Serum creatinine level ≥ 1.5 times the upper limit of normal

 Thyroid-stimulating hormone ≤ 0.1 μU/mL or ≥ 10 μU/mL

 Use of drugs, herbs or supplements known to significantly affect body weight (anti-obesity agents, anti-depressant drugs, glucocorticoids, laxatives, oral contraceptives, female hormones, etc.) in the past 3 months

 Significant cardiac events within the past 6 months

 History of malignancy within the past 5 years

 Allergic disease, including bronchial asthma

 Cardiac disease, cerebrovascular disease, pulmonary disease, endocrine disease, renal disease, gout, porphyria

 Gastrointestinal disease, liver disease, gallbladder disease, pancreatic disease, malabsorption syndrome

 Psychiatric disorder, including major depression, schizophrenia, bulimia, alcohol abuse, or substance abuse

 History of abdominal adhesion after surgery

 History of obesity surgery

 Weight loss greater than 4 kg within the past 3 months

 Pregnant or breastfeeding women

 Women of childbearing age not adhering to acceptable forms of contraception

 Participants in another clinical trial within the past 1 month

  1. AST Aspartate aminotransferase, ALT Alanine aminotransferase