Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

Inclusion Criteria:

• 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 bloodglucose(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 ofself-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 becomepregnant or are not using adequate contraceptive methods

• Impaired liver function, defined as Aspartate aminotransferase(AST) or Alaninetransaminase(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≥160mmHgand /or diastolic blood pressure≥95mmHg)

• Chronic gastrointestinal diseases

• Cancer and medical history of cancer (except basal cell skin cancer or squamous cellskin cancer)

• Any clinically significant disease or disorder, which in the Investigator's opinioncould interfere with the results of the trial

• Mental incapacity, psychiatric disorder, unwillingness or language barriers precludingadequate 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 therecruitment period

• Known or suspected hypersensitivity to trial products or related products

• Known or suspected abuse of alcohol, narcotics or illicit drugs.