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AzTrials

HealthyNCT06864364

Effect of Visualization of Functional Milk Efficacy on Perceived Benefits

A study testing CGM feedback visualization, milk supplemented with mulberry leaves extract and blinded CGM feedback visualization 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 study aims to demonstrate the effect of visualizing the effect of consuming a functional milk on postprandial glucose response on perceived benefits compared to absence of visualization. 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, Asian
What is being tested?
CGM feedback visualization, milk supplemented with mulberry leaves extract and blinded CGM feedback visualization
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
1 siteChina
Study dates
24 Feb 2025to 12 Nov 2025
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 understand and sign a written informed consent prior to study entry
  • Deemed able to comply with the requirements of the study protocol and consume study product
  • BMI: 18.5-35.0 kg/m2 (inclusive)
  • Age: 45-75y (inclusive 45 and 75)
  • Males and females
  • HbA1c ≤ 6.4 % and FPG ≤ 6.90 mmol/L (125 mg/dl) to exclude diabetic individuals based on the National Institute of Health and Care (NICE) criteria
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  • Regularly consuming a carbohydrate containing breakfast (≥30g of total CHO) assessed by a food recall only at breakfast of the previous day to the screening visit
  • Having a sedentary lifestyle meaning do not usually conduct vigorous*-intense physical activity and are willing to abstain from it during reference and intervention period
  • If on chronic medication such as lipid-lowering, thyroid medication, etc., the dosage must be constant for at least 3 months prior to screening.
  • Activities such as jogging, running, carrying heavy objects or other loads upstairs, shoveling snow, participating in a fitness class, and fast swimming, that will lead to hard and fast breathing.

Who cannot join

  • Pre-existing chronic medical condition and/or history of significant medical condition (e.g. malignancy, significant organ dysfunction, autoimmune and/ or genetic disease, gastrointestinal disease, endocrine disease (e.g. diabetes mellitus, history of hypoglycemia, polycystic disease syndrome, Addison's disease, Cushing's syndrome, acromegaly), acute or chronic infectious condition (e.g. hepatitis B and C, HIV, tuberculosis), cardiovascular disease (heart failure, angina, myocardial infarction, stroke), renal disease (renal insufficiency), hepatic (liver cirrhosis, liver failure) or respiratory disease (COPD), hematological disorder (e.g. anemia), neurological and/or psychiatric conditions (e.g. depression, psychotic disorders, chronic insomnia eating disorder), as diagnosed by the treating physician, which in the opinion of the site physician/ investigator may risk participant wellbeing/ safety, impede participant compliance with study procedures or ability to complete the study and/ or could confound the primary objectives of the study.
  • Any acute illness or any recent medical/ surgical intervention within 3 months prior to enrolment potentially interfering with study procedures and assessments.
  • Known or suspected cow's milk protein allergy (CMPA), lactose and /or soy intolerance /hypersensitivity.
  • Known substance abuse or alcohol user exceeds following intake on a regular basis, alcohol intake > 2 servings per day for males and > 1 servings per day for females. A serving is 40ml of strong alcohol, 100 ml of red or white wine, or 300 ml of beer.
  • Current smoker (e.g., cigarette, tobacco, cannabis) who exceeds 5 cigarettes per week.
  • Patients with refractory hypertension, and patients with hypertension who are taking antihypertensive drugs (beta-blockers, thiazide diuretics) that may affect blood glucose metabolism.
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  • Female participants 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.
  • Participants on systemic corticosteroids, glucocorticoids, or cyclosporine A.
  • Female participants who are pregnant or intending to become pregnant, lactating and or breastfeeding.
  • Participants who had a significant weight loss (≥5%) within the last 6 months or follow a weight loss programme.
  • Following diets with low carbohydrate content (e.g., ketogenic diet, Atkins diet, low-carb diet, carb cycling diet), intermittent fasting, breakfast skippers or any self-restricted, controlled, or special therapeutic diet.
  • Participants who do not regularly (≤ 3 times per week) drink dairy milk.
  • Use of multivitamin/ multimineral supplements (including vitamin C, supplements fiber-based or derived of leaf extracts or known to/intended to lower blood glucose as per package claim) up to 15 days prior to screening.
  • Medically known cutaneous hypersensitivity to adhesives, silicon watchstrap and plasters.
  • High daily coffee consumption (≥400 mg of caffeine/day, equivalent to ≥4 cups of coffee).
  • Currently participating in another interventional clinical study.
  • Having two (or more) participants from the same household already enrolled in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen Memorial Hospital

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: Effect of Continuous Glucose Monitoring on Perceived Benefits of a Milk With Mulberry Leave Extract in Non-diabetic Adult Chinese Population

This study aims to demonstrate the effect of visualizing the effect of consuming a functional milk on postprandial glucose response on perceived benefits compared to absence of visualization.

Read the detailed description

This is a multi-centric double-blind, randomized, 2-arm parallel group clinical study to investigate the effect of of consuming a functional milk on postprandial glucose response on perceived benefits compared to absence of visualization.

The study is divided in 3 periods: 1) reference period in which both groups will have a blinded Continuous Glucose Monitoring (CGM) sensor; 2) intervention period where participants will have either CGM feedback visualization or blinded CGM feedback visualization, while both arms consume a functional milk powder; 3) follow-up in free-living conditions.

Outcomes of this study will include plasma HbA1c, glucose, insulin and lipids levels, perceived benefits and adherence questionnaire, dietary intake and physical activity and real usage.

This will be conducted in a total of 170 healthy adults of Chinese ethnicity aged 45-75 years

Being tested
CGM feedback visualization, milk supplemented with mulberry leaves extract, blinded CGM feedback visualization
Keywords
CGM, perceived benefit
Medical subject headings
Prediabetic State

What participants receive

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

  • CGM feedback visualizationOther

    The subject will have CGM feedback visualization

  • milk supplemented with mulberry leaves extractDietary supplement

    milk supplemented with mulberry leaves extract

  • blinded CGM feedback visualizationOther

    The subject will have blinded CGM feedback visualization

Study groups in NCT06864364
Study groupRoleWhat they receive
Visualization (intervention arm, group A)ExperimentalCGM feedback visualization
Receives: Other: CGM feedback visualization; Dietary Supplement: milk supplemented with mulberry leaves extract
Blinded Visualization (control arm, group B)Placebo comparatorblinded for CGM feedback visualization
Receives: Dietary Supplement: milk supplemented with mulberry leaves extract; Other: blinded CGM feedback visualization

What is being measured

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

  1. Likert-scale for perceived benefit

    A Likert-scale from 1 (very unlikely) to 7 (very likely) on perceived product benefits

    Measured: From enrollment to day 30

Secondary outcomes (11)

  1. Likert-scale for product experience

    A Likert-scale from 1 (very unlikely) to 7 (very likely) on product experience.

    Measured: From enrollment to day 15 and day 30

  2. Likert-scale for perceived benefit

    A Likert-scale from 1 (very unlikely) to 7 (very likely) on perceived product benefits.

    Measured: From enrollment to day 15

  3. Actual usage and recommendation behavior

    Actual usage and recommendation behavior will be measured comparing answers at the end of the follow up period (V6) from Group A vs. Group B to 5 questions generated for this study.

    1. Have you bought Yiyang TangLv since the intervention ended (visit 5)? Yes No 1.1 If so, how many tins or/and sachet did you buy? (Specify number) This includes for yourself or family ___ tins
    • sachets
    1. How often have you drank Yiyang TangLv since the end intervention (visit 5)? Never <3 times a week 4-6 days a week 7 days a week
    2. Did you drank it in the morning with breakfast? Yes No
    3. Has anyone else in your household drank Yiyang TangLv since the intervention ended (visit 5)? Yes No not sure
    4. Have you recommended Yiyang TangLv to anyone since the study end of the intervention (visit 5)? Yes No

    Measured: At day 88

  4. CGM markers - iAUC0-60,120,180 min post-breakfast

    Changes in CGM markers in response to IP intake (mmol/L x min) .

    Measured: From enrollment to day 30

  5. CGM markers - 24h iAUC

    Changes in CGM markers. (mmol/L x min)

    Measured: From enrollment to day 30

  6. CGM markers - iCmax

    Changes in CGM markers in response to IP intake (mmol/L) .

    Measured: From enrollment to day 30

  7. CGM markers - Tmax

    Changes in CGM markers in response to IP intake (min).

    Measured: From enrollment to day 30

  8. CGM markers - time in range (TIR)

    Changes in CGM markers (%).

    Measured: From enrollment to day 30

  9. CGM markers - average interstitial glucose

    Changes in CGM markers (mmol/L).

    Measured: From enrollment to day 30

  10. CGM markers - coefficient of variance (CV)

    Changes in CGM markers (%) .

    Measured: From enrollment to day 30

  11. CGM markers - mean amplitude of glycaemic excursion (MAGE)

    Changes in CGM markers (mmol/L) .

    Measured: From enrollment to day 30

Timeline

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

  1. First posted7 Mar 2025
  2. Study start24 Feb 2025
  3. Primary completion15 Sep 2025
  4. Study completion12 Nov 2025

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06864364
Sponsor's protocol ID
2301NR
Status last verified
Feb 2026
First submitted
6 Feb 2025
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CGM feedback visualization, milk supplemented with mulberry leaves extract and blinded CGM feedback visualization 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 10 inclusion and 17 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 12 Feb 2026. 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. Some participants in this study may receive a placebo. 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?

Likert-scale for perceived benefit (time frame: From enrollment to day 30). 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 NCT06864364.

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 12 Feb 2026.

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