Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response
Evaluate Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response: an Acute Study in Chinese Population
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Nov 2022
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedStudy Start
First participant enrolled
November 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2023
CompletedJune 27, 2025
June 1, 2025
4 months
September 20, 2022
June 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3h-iAUC of PPGR
Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR)
3 hours
Secondary Outcomes (8)
iAUC of PPGR
1hour, 2 hours
Tmax of PPGR
3 hours
Cmax of PPGR
3 hours
iCmax of PPGR
3 hours
iAUC of PPIR
1 hour, 2 hours
- +3 more secondary outcomes
Other Outcomes (1)
additional endpoints slopes derived from PPGR
0, 15, 30 min or 1 hour, 2 hours, 3 hours
Study Arms (2)
YIYANG TangLv milk powder
EXPERIMENTAL30g 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
ACTIVE COMPARATOR25g of commercially available skimmed milk powder reconstituted with 180 ml of warm water.
Interventions
Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Related Publications (1)
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.
PMID: 40419093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Chen
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2022
First Posted
October 6, 2022
Study Start
November 16, 2022
Primary Completion
March 14, 2023
Study Completion
March 14, 2023
Last Updated
June 27, 2025
Record last verified: 2025-06