Pre-biabetes
Conditions
Brief summary
This study aims to conduct a 8-week probiotics intervention involving for middle-aged and elderly individuals with pre-diabetes, assessing its impact on blood glucose control in comparison to placebo
Interventions
DIETARY_SUPPLEMENTa special probiotics from Mengniu Group, supplemented with milk powder
Sorbitol 、Xylitol 、Paracaseobacterium LC19 、Bifidobacterium lactis subsp. animalis MN-Gup 、Mulberry Leaf Extract 、Bitter Melon Powder 、Resistant Dextrin 、White Kidney Bean Extract 、Stachyose 、Galactooligosaccharides 、Food Flavoring、Mono- and Diglycerides of Fatty Acids 、Silicon Dioxide
DIETARY_SUPPLEMENTregular milk powder does not contain any additional supplementation, and the color, flavor, shape, taste, and weight are same with the probiotic milk powder
Sorbitol、Xylitol 、Food Flavoring 、Mono- and Diglycerides of Fatty Acids 、Silicon Dioxide、Maltodextrin
Sponsors
Huilian Zhu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 40 and 75 years, regardless of gender. 2. Impaired fasting glucose (5.6 mmol/L ≤ FPG \< 6.9 mmol/L) or glycated hemoglobin (HbA1c) between 5.7-6.4% (39-47 mmol/mol). 3. Resided in Guangzhou for the past six months and no plans to relocate or travel outside the city in the next month. 4. Signed informed consent form and voluntarily agreed to participate in the project.
Exclusion criteria
1. Patients with a confirmed diagnosis of diabetes who are currently taking glucose-lowering medications (e.g., insulin, GLP-1 receptor agonists, or SGLT2 inhibitors). 2. Individuals with lactose intolerance or dairy product intolerance. 3. Pregnant, planning to become pregnant within the next three months, or currently breastfeeding. 4. Weight change \> 5% in the past three months or plans to lose weight or change dietary habits. 5. Alcohol consumption \> 40g/day. 6. Individuals with communication barriers, cognitive impairments, or other conditions that may prevent them from completing the study procedures. 7. Severe diseases that may affect participation in the study, including but not limited to endocrine disorders, severe cardiovascular or cerebrovascular diseases, cancer, metabolic diseases, etc. 8. Participation in or current involvement in other clinical trials within the past three months. 9. No use of antibiotic medications within the past three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fasting blood glucose | up to 8 weeks | At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose. |
| 2h-piAUC after standardized breakfast | up to 8 weeks | the positive increment of area under curve in 2 hours after standardized breakfast standardized breakfast, measured by continuous glucose monitoring at baseline, and 8 weeks. |
| TIR (time in range) | up to 8 weeks | TIR refers to the time when blood glucose is controlled within a reasonable ( target ) range (3.9\ 10.0 mmol/L), measured by continuous glucose monitoring at baseline and 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipid metabolism | up to 8 weeks | At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine total cholesterol, low density lipoprotein, high density lipoprotein, triglyceride. |
| sleep quality | up to 8 weeks | At baseline, and 8 weeks, investigators will use the Pittsburgh sleep quality index scale to examine sleep quality. |
| HbA1c | up to 8 weeks | At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c. |
| Continuous Glucose Monitoring (CGM) Data | up to 8 weeks | At baseline, and 8 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants |
| blood pressure | up to 8 weeks | At baseline, and 8 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor |
| weight | up to 8 weeks | t baseline, and 8 weeks, investigators will examine weight. |
| intestinal bacteria | up to 8 weeks | At baseline, and 8 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria. |
Outcome results
None listed