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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
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This is a monocentric, randomized controlled, open-label, 2x2 cross-over study. The main objective of the study is to Evaluate the efficacy of Nestle YIYANG TangLv milk powder in lowering the Post Prandial Glucose Response (PPGR) of a high carbohydrate meal when consumed with the meal.
This is an acute, monocentric, open label, randomized, 2-arm, cross-over, clinical trial in 30 subjects of Chinese Han ethnicity. Subjects will receive the two different interventions in a randomized order. This study will assess the efficacy of the investigational product after a single consumption. Day before (V1 and V3) the intervention visits (V2 and V4) the subjects will be admitted at the investigational site for an overnight stay where they will consume a standardized dinner. V2 and V3 will be followed by a wash-out period of 3 days. The two arms are:
Arm 1: skimmed milk (control) Arm 2: Nestle YIYANG TangLv milk powder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YIYANG TangLv milk powder | Experimental | 30g of milk powder (Nestle YIYANG TangLv milk powder) containing 789 mg Reducose® extract, standardized to contain 1% 1-deoxynojirimycin (1-DNJ), 10% of an oil mix and 8% of soluble fiber reconstituted with 180 ml of warm water. |
|
| skimmed milk | Active Comparator | 25g of commercially available skimmed milk powder reconstituted with 180 ml of warm water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Biological | Blood collection for glucose, insulin, GLP-1, GIP and C-peptide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3h-iAUC of PPGR | Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR) | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| iAUC of PPGR | Incremental area under the curve of PPGR (Postprandial Glucose Response) | 1hour, 2 hours |
| Tmax of PPGR | Tmax(the time when Cmax is achieved) of PPGR (Postprandial Glucose Response) |
| Measure | Description | Time Frame |
|---|---|---|
| additional endpoints slopes derived from PPGR | additional endpoints slopes derived from PPGR | 0, 15, 30 min or 1 hour, 2 hours, 3 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Chen | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40419093 | Derived | Cherta-Murillo A, Xu H, Moullan N, Tadi M, Huang F, Kodakuthumparambil N, Campos VC, Li J, Fu Q, Li Q, Huang H, Rytz A, Darimont C, Chen W. Milk with Mulberry Leaf Extract, Vegetable Oil, and Inulin Reduce Early Glucose and Insulin Response in Healthy Adults in China: Randomized Controlled Trial. J Nutr. 2025 Jul;155(7):2227-2235. doi: 10.1016/j.tjnut.2025.05.036. Epub 2025 May 24. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 3 hours |
| Cmax of PPGR | Cmax(maximal value of measured timepoints) of PPGR (Postprandial Glucose Response) | 3 hours |
| iCmax of PPGR | iCmax( maximal incremental value ) of PPGR (Postprandial Glucose Response) | 3 hours |
| iAUC of PPIR | Incremental area under the curve of PPIR (Postprandial Insulin Response) | 1 hour, 2 hours |
| Tmax of PPIR | Tmax(the time when Cmax is achieved) of PPIR (Postprandial Insulin Response) | 3 hours |
| Cmax of PPIR | Cmax(maximal value of measured timepoints) of PPIR (Postprandial Insulin Response) | 3 hours |
| iCmax of PPIR | iCmax( maximal incremental value ) of PPIR (Postprandial Insulin Response) | 3 hours |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |