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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotics group | Experimental | a special probiotics from Mengniu Group, supplemented with milk powder |
|
| placebo group | Placebo Comparator | regular milk powder does not contain any additional supplementation, and the color, flavor, shape, taste, and weight are same with the probiotic milk powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a special probiotics from Mengniu Group, supplemented with milk powder | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| fasting blood glucose | At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose. | up to 8 weeks |
| 2h-piAUC after standardized breakfast | 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. | up to 8 weeks |
| TIR (time in range) | 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. | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c. | up to 8 weeks |
| weight | t baseline, and 8 weeks, investigators will examine weight. |
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Inclusion Criteria:
Exclusion Criteria:
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|
| regular milk powder does not contain any additional supplementation, and the color, flavor, shape, taste, and weight are same with the probiotic milk powder | Dietary Supplement | Sorbitol、Xylitol 、Food Flavoring 、Mono- and Diglycerides of Fatty Acids 、Silicon Dioxide、Maltodextrin |
|
| up to 8 weeks |
| intestinal bacteria | At baseline, and 8 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria. | up to 8 weeks |
| lipid metabolism | At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine total cholesterol, low density lipoprotein, high density lipoprotein, triglyceride. | up to 8 weeks |
| sleep quality | At baseline, and 8 weeks, investigators will use the Pittsburgh sleep quality index scale to examine sleep quality. | up to 8 weeks |
| blood pressure | At baseline, and 8 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor | up to 8 weeks |
| Continuous Glucose Monitoring (CGM) Data | At baseline, and 8 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants | up to 8 weeks |
| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| D013649 | Taste |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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