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This study aims to conduct a 8-week intervention involving one formula milk powder for middle-aged and elderly individuals with pre-diabetes, assessing its impact on blood glucose control and fluctuations in comparison to interventions using regular milk powder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fortified formula milk powder group | Experimental | Fortified formula milk powder is supplemented with fiber, bitter gourd powder,mulberry leaves extract, whitekidney beans extract, and probiotics, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day for a duration of 8 weeks. |
|
| regular milk powder group | Placebo Comparator | Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fortified formula milk powder group | Dietary Supplement | Fortified formula milk powder is supplemented with fiber, bitter gourd powder,mulberry leaves extract, whitekidney beans extract, and probiotics, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day for a duration of 8 weeks. |
| 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 | At baseline, and 8 weeks, investigators will examine weight. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| regular milk powder group | Dietary Supplement | Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. |
|
| 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 |