Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

• Informed consent obtained before any trial-related activities
• Male or female between 18 and 70 years of age
• 19≤Body mass index(BMI)≤30kg/m2
• No participate in any clinical trial at least 3 months
• Fasting blood glucose(FBG)\<7.0mmol/L and 2-hour postprandial blood glucose(2hPBG)\<11.1mmol/L
• Females in child-bearing period should be given birth control
• No severe disease about heart, lung and kidney
• Ability and willingness to adhere to the protocol including performance of self-monitored blood glucose (SMBG) profiles according to the protocol;
• Subject is likely to comply with the Investigators instruction.

Exclusion Criteria:

• Type 2 diabetes mellitus or type 1 diabetes mellitus
• Females of childbearing potential who are pregnant，breastfeeding or intend to become pregnant or are not using adequate contraceptive methods
• Impaired liver function, defined as Aspartate aminotransferase(AST) or Alanine transaminase(ALT)> 2 times upper limit of normal (central laboratory)
• Impaired renal function, defined as serum-creatinine≥133μmol/L
• Uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmHg and /or diastolic blood pressure≥95mmHg)
• Chronic gastrointestinal diseases
• Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
• Any clinically significant disease or disorder, which in the Investigator's opinion could interfere with the results of the trial
• Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read and write
• Previous participation in this trial. Participation is defined as randomized. Re-screening of screening failures is allowed only once within the limits of the recruitment period
• Known or suspected hypersensitivity to trial products or related products
• Known or suspected abuse of alcohol, narcotics or illicit drugs.