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

Not Applicable

Completed

• Conditions: PreDiabetes; Healthy; Adult; Asian
• Interventions: Biological: Blood collection

• Registration Number: NCT05570435
• Lead Sponsor: Société des Produits Nestlé (SPN)

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

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-06
• Study Start: 2022-11-16
• Primary Completion: 2023-03-14
• Study Completion: 2023-03-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
YIYANG TangLv milk powder	Blood collection	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	Blood collection	25g of commercially available skimmed milk powder reconstituted with 180 ml of warm water.

Primary Outcome Measures

Name	Time	Method
3h-iAUC of PPGR	3 hours	Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR)

Secondary Outcome Measures

Name	Time	Method
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)
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)
Tmax of PPIR	3 hours	Tmax(the time when Cmax is achieved) of PPIR (Postprandial Insulin Response)
iCmax of PPGR	3 hours	iCmax( maximal incremental value ) of PPGR (Postprandial Glucose Response)
Cmax of PPIR	3 hours	Cmax(maximal value of measured timepoints) of PPIR (Postprandial Insulin Response)

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China