Adult, Asian, Healthy, PreDiabetes
Conditions
Keywords
Nestle, postprandial glucose, incretins, insulin, healthy
Brief summary
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
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
Interventions
BIOLOGICALBlood collection
Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.
Sponsors
Peking Union Medical College Hospital
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to sign written informed consent prior to trial entry 2. Deemed able to comply with study protocol for 2-3 weeks 3. Male or female aged 45-75 years (inclusive 45 and 75) 4. HbA1c test results \< 6.5% at Visit 1 (Admission 1) 5. Waist circumference ≤90 cm in males and ≤ 85 cm in females 6. Chinese Han ethnic group 7. BMI \>18.5 and \<28 kg/m2
Exclusion criteria
1. 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) 2. Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments 3. 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 4. 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 5. Consumption of tobacco products, smoking or chewing tobacco 6. History of significant organ dysfunction or disease 7. Subjects with refractory hypertension, and patients with hypertension who are taking antihypertensive drugs (beta-blockers, thiazide diuretics, etc.) that may affect blood glucose metabolism 8. 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 9. Known autoimmune and/or genetic disease 10. Known chronic diarrhea or gastrointestinal discomfort 11. Known endocrine and metabolic diseases under drug treatment (e.g., pituitary tumors, thyrotoxicosis due to various causes, Cushing's syndrome etc.) 12. Subjects on systemic corticosteroids, glucocorticoids, or cyclosporine A 13. Recent blood donation (\<8 weeks) 14. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3h-iAUC of PPGR | 3 hours | Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| iCmax of PPIR | 3 hours | iCmax( maximal incremental value ) of PPIR (Postprandial Insulin Response) |
| iAUC of PPGR | 1hour, 2 hours | Incremental area under the curve of PPGR (Postprandial Glucose Response) |
| Tmax of PPGR | 3 hours | Tmax(the time when Cmax is achieved) of PPGR (Postprandial Glucose Response) |
| Cmax of PPGR | 3 hours | Cmax(maximal value of measured timepoints) of PPGR (Postprandial Glucose Response) |
| iAUC of PPIR | 1 hour, 2 hours | Incremental area under the curve of PPIR (Postprandial Insulin Response) |
| Tmax of PPIR | 3 hours | Tmax(the time when Cmax is achieved) of PPIR (Postprandial Insulin Response) |
| Cmax of PPIR | 3 hours | Cmax(maximal value of measured timepoints) of PPIR (Postprandial Insulin Response) |
| iCmax of PPGR | 3 hours | iCmax( maximal incremental value ) of PPGR (Postprandial Glucose Response) |
Other
| Measure | Time frame | Description |
|---|---|---|
| additional endpoints slopes derived from PPGR | 0, 15, 30 min or 1 hour, 2 hours, 3 hours | additional endpoints slopes derived from PPGR |
Countries
China
Outcome results
None listed