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

NCT ID: NCT05570435

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2023-03-14

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

Conditions

Healthy; PreDiabetes; Adult; Asian

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

YIYANG TangLv milk powder

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.

Group Type: EXPERIMENTAL

Blood collection

Intervention Type: BIOLOGICAL

Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.

skimmed milk

25g of commercially available skimmed milk powder reconstituted with 180 ml of warm water.

Group Type: ACTIVE_COMPARATOR

Blood collection

Intervention Type: BIOLOGICAL

Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.

Interventions

Blood collection

Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Chen

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40419093 (View on PubMed)

Other Identifiers

21.16.NR

Identifier Type: -

Identifier Source: org_study_id