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HealthyNCT05570435

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

A study testing Blood collection in people with Healthy and PreDiabetes, run by Société des Produits Nestlé (SPN) at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, PreDiabetes, Adult
What is being tested?
Blood collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
16 Nov 2022to 14 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

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

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.

Read the 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

Being tested
Blood collection
Keywords
Nestle, postprandial glucose, incretins, insulin, healthy
Medical subject headings
Prediabetic State, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood collectionBiological

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

Study groups in NCT05570435
Study groupRoleWhat they receive
YIYANG TangLv milk powderExperimental30g 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.
Receives: Biological: Blood collection
skimmed milkActive comparator25g of commercially available skimmed milk powder reconstituted with 180 ml of warm water.
Receives: Biological: Blood collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3h-iAUC of PPGR

    Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR)

    Measured: 3 hours

Secondary outcomes (8)

  1. iAUC of PPGR

    Incremental area under the curve of PPGR (Postprandial Glucose Response)

    Measured: 1hour, 2 hours

  2. Tmax of PPGR

    Tmax(the time when Cmax is achieved) of PPGR (Postprandial Glucose Response)

    Measured: 3 hours

  3. Cmax of PPGR

    Cmax(maximal value of measured timepoints) of PPGR (Postprandial Glucose Response)

    Measured: 3 hours

  4. iCmax of PPGR

    iCmax( maximal incremental value ) of PPGR (Postprandial Glucose Response)

    Measured: 3 hours

  5. iAUC of PPIR

    Incremental area under the curve of PPIR (Postprandial Insulin Response)

    Measured: 1 hour, 2 hours

  6. Tmax of PPIR

    Tmax(the time when Cmax is achieved) of PPIR (Postprandial Insulin Response)

    Measured: 3 hours

  7. Cmax of PPIR

    Cmax(maximal value of measured timepoints) of PPIR (Postprandial Insulin Response)

    Measured: 3 hours

  8. iCmax of PPIR

    iCmax( maximal incremental value ) of PPIR (Postprandial Insulin Response)

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2022
  2. Study start16 Nov 2022
  3. Primary completion14 Mar 2023
  4. Study completion14 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05570435
Sponsor's protocol ID
21.16.NR
Status last verified
Jun 2025
First submitted
20 Sep 2022
Last updated
27 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40419093

Questions about this trial

What is this clinical trial studying?

A study testing Blood collection in people with Healthy and PreDiabetes, run by Société des Produits Nestlé (SPN) at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3h-iAUC of PPGR (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05570435, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.

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