Effect of Visualization of Functional Milk Efficacy on Perceived Benefits

NCT06864364 | Completed

• 1 other identifier: 2301NR
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asian; Adult; Prediabetes; Healthy

Keywords

CGM; perceived benefit

Outcome Measures

Primary Outcomes (1)

• Likert-scale for perceived benefit

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

  From enrollment to day 30

Secondary Outcomes (11)

• Likert-scale for product experience

  From enrollment to day 15 and day 30

• Likert-scale for perceived benefit

  From enrollment to day 15

• Actual usage and recommendation behavior

  At day 88

• CGM markers - iAUC0-60,120,180 min post-breakfast

  From enrollment to day 30

• CGM markers - 24h iAUC

  From enrollment to day 30

Other Outcomes (16)

• Long-term glucose metabolism -HbA1c

  From day 0 to day 88

• International physical activity questionnaire

  From enrollment to day 88

• Macronutrient and energy intake

  From enrollment to day 88

Study Arms (2)

Visualization (intervention arm, group A)

EXPERIMENTAL

CGM feedback visualization

Other: CGM feedback visualization; Dietary Supplement: milk supplemented with mulberry leaves extract

Blinded Visualization (control arm, group B)

PLACEBO COMPARATOR

blinded for CGM feedback visualization

Dietary Supplement: milk supplemented with mulberry leaves extract; Other: blinded CGM feedback visualization

Interventions

milk supplemented with mulberry leaves extract DIETARY_SUPPLEMENT

milk supplemented with mulberry leaves extract

Blinded Visualization (control arm, group B); Visualization (intervention arm, group A)

blinded CGM feedback visualization OTHER

The subject will have blinded CGM feedback visualization

Blinded Visualization (control arm, group B)

CGM feedback visualization OTHER

The subject will have CGM feedback visualization

Visualization (intervention arm, group A)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Sun Yat-sen University: collaborator
• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: March 7, 2025
• Study Start: February 24, 2025
• Primary Completion: September 15, 2025
• Study Completion: November 12, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CN (1)