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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
31
Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
3h-iAUC of PPGR
Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR)
Time frame: 3 hours
iAUC of PPGR
Incremental area under the curve of PPGR (Postprandial Glucose Response)
Time frame: 1hour, 2 hours
Tmax of PPGR
Tmax(the time when Cmax is achieved) of PPGR (Postprandial Glucose Response)
Time frame: 3 hours
Cmax of PPGR
Cmax(maximal value of measured timepoints) of PPGR (Postprandial Glucose Response)
Time frame: 3 hours
iCmax of PPGR
iCmax( maximal incremental value ) of PPGR (Postprandial Glucose Response)
Time frame: 3 hours
iAUC of PPIR
Incremental area under the curve of PPIR (Postprandial Insulin Response)
Time frame: 1 hour, 2 hours
Tmax of PPIR
Tmax(the time when Cmax is achieved) of PPIR (Postprandial Insulin Response)
Time frame: 3 hours
Cmax of PPIR
Cmax(maximal value of measured timepoints) of PPIR (Postprandial Insulin Response)
Time frame: 3 hours
iCmax of PPIR
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iCmax( maximal incremental value ) of PPIR (Postprandial Insulin Response)
Time frame: 3 hours