Hyperglycemia and hyperlipidemia
Conditions
Interventions
Placebo group:Subjects will take a daily packet containing 4g/9g of maltodextrin (dose to be determined after a pilot study) dissolved in warm water for 12 consecutive weeks
Low-dose intervention group:Subjects will take a daily packet containing either 1g 2'-fucosyl lactose + 3g maltodextrin or 1g 2'-fucosyl lactose + 8g maltodextrin (dosage to be determined after a pilo
Middle-dose intervention group:Subjects will take a daily packet containing either 2g 2'-fucosyl lactose + 2g maltodextrin or 3g 2'-fucosyl lactose + 6g maltodextrin (dosage to be determined after a p
High-dose intervention group:Subjects will take a daily packet containing 4g/9g of 2'-fucosyl lactose (dose to be determined after a pilot study) dissolved in warm water for 12 consecutive weeks
Sponsors
China Agricultural University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 45-65, capable of independent action, cognitively normal, and willing to participate in this study; no gastrointestinal-related diseases; 2. Have not received treatment with hypoglycemic or lipid-lowering drugs; 3. Diagnosed with impaired glucose tolerance (pre-diabetes) according to the 2023 diagnostic criteria of the American Diabetes Association (BMI 19.0–35.0 kg/m^2; fasting blood glucose >=5.6 mmol/L and =5.7% and =6.22 mmol/L), low-density lipoprotein cholesterol (LDL-C) >=4.14 mmol/L, high-density lipoprotein cholesterol (HDL-C) =2.26 mmol/L; 5. No hospitalization records in the past 3 months;6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe heart, liver, or kidney diseases; 2. Those who have used medications for diabetes, dyslipidemia, or hypertension; 3. Those who have used antibiotics within the past 3 months; 4. Those who regularly take (more than once a week) high doses of probiotics or prebiotics; 5. Individuals with gastrointestinal-related diseases; 6. Alcoholics; 7. Those allergic to any components used in the study; 8. Other reasons deemed by the investigator that make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI;Waist-Hip Ratio;Glucose;glycosylated hemoglobin;Insulin;Total cholesterol;Triglyceride;Low density lipoprotein cholesterin;High density lipoprotein cholesterol; | — |
Countries
China
Contacts
Public ContactChe Huilian
China Agricultural University
Outcome results
None listed