Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluate Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response: an Acute Study in Chinese Population

Conditions
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Healthy, PreDiabetes, Adult, Asian

Intervention / Treatment
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* Biological: Blood collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to sign written informed consent prior to trial entry Deemed able to comply with study protocol for 2-3 weeks Male or female aged 45-75 years (inclusive 45 and 75) HbA1c test results < 6.5% at Visit 1 (Admission 1) Waist circumference ≤90 cm in males and ≤ 85 cm in females Chinese Han ethnic group BMI >18.5 and <28 kg/m2 Exclusion Criteria: Pre-existing chronic medical or psychiatric conditions, as diagnosed by the treating physician (psychiatric illness, asthma or chronic lung disease requiring long term medications or oxygen, diabetes mellitus, chronic infective disease, including tuberculosis, hepatitis B and C, and HIV) Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments Known food allergy in particular cow's milk protein allergy (CMPA), lactose and /or soy intolerance or known hypersensitivity/intolerance to any other ingredients in the study product Known substance abuse or alcohol user exceeds following intake, alcohol intake > 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer Consumption of tobacco products, smoking or chewing tobacco History of significant organ dysfunction or disease Subjects with refractory hypertension, and patients with hypertension who are taking antihypertensive drugs (beta-blockers, thiazide diuretics, etc.) that may affect blood glucose metabolism Females currently on hormonal therapy including post-menopausal hormone replacement therapy (PRT) or have been on PRT treatment in the past two months before study participation Known autoimmune and/or genetic disease Known chronic diarrhea or gastrointestinal discomfort Known endocrine and metabolic diseases under drug treatment (e.g., pituitary tumors, thyrotoxicosis due to various causes, Cushing's syndrome etc.) Subjects on systemic corticosteroids, glucocorticoids, or cyclosporine A Recent blood donation (<8 weeks) Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YIYANG TangLv milk powder<br>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. | Biological: Blood collection<br>* Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.<br>|
| Active Comparator: skimmed milk<br>25g of commercially available skimmed milk powder reconstituted with 180 ml of warm water. | Biological: Blood collection<br>* Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nestle, postprandial glucose, incretins, insulin, healthy