Clinical trial NCT06864364: Effect of Visualization of Functional Milk Efficacy on Perceived Benefits
Official title: Effect of Continuous Glucose Monitoring on Perceived Benefits of a Milk with Mulberry Leave Extract in Non-diabetic Adult Chinese Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Prediabetes
Asian
Adult
Keywords: CGM
perceived benefit
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Sun Yat-sen University
First posted: 2025-03-07
Enrollment: 184
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 184 healthy adults of Chinese ethnicity aged 45-75 years

Eligibility criteria: Inclusion Criteria:

1. Willing and able to understand and sign a written informed consent prior to study entry
2. Deemed able to comply with the requirements of the study protocol and consume study product
3. BMI: 18.5-35.0 kg/m2 (inclusive)
4. Age: 45-75y (inclusive 45 and 75)
5. Males and females
6. 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
7. 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
8. 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
9. 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.

Exclusion Criteria:

1. 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.
2. Any acute illness or any recent medical/ surgical intervention within 3 months prior to enrolment potentially interfering with study procedures and assessments.
3. Known or suspected cow's milk protein allergy (CMPA), lactose and /or soy intolerance /hypersensitivity.
4. 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.
5. Current smoker (e.g., cigarette, tobacco, cannabis) who exceeds 5 cigarettes per week.
6. Patients with refractory hypertension, and patients with hypertension who are taking antihypertensive drugs (beta-blockers, thiazide diuretics) that may affect blood glucose metabolism.
7. 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.
8. Participants on systemic corticosteroids, glucocorticoids, or cyclosporine A.
9. Female participants who are pregnant or intending to become pregnant, lactating and or breastfeeding.
10. Participants who had a significant weight loss (≥5%) within the last 6 months or follow a weight loss programme.
11. 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.
12. Participants who do not regularly (≤ 3 times per week) drink dairy milk.
13. 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.
14. Medically known cutaneous hypersensitivity to adhesives, silicon watchstrap and plasters.
15. High daily coffee consumption (≥400 mg of caffeine/day, equivalent to ≥4 cups of coffee).
16. Currently participating in another interventional clinical study.
17. Having two (or more) participants from the same household already enrolled in the study.

Primary outcomes:
measure: Likert-scale for perceived benefit
timeFrame: From enrollment to day 30
Secondary outcomes:
measure: Likert-scale for product experience
timeFrame: From enrollment to day 15 and day 30
measure: Likert-scale for perceived benefit
timeFrame: From enrollment to day 15
measure: Actual usage and recommendation behavior
timeFrame: At day 88
measure: CGM markers - iAUC0-60,120,180 min post-breakfast
timeFrame: From enrollment to day 30
measure: CGM markers - 24h iAUC
timeFrame: From enrollment to day 30
measure: CGM markers - iCmax
timeFrame: From enrollment to day 30
measure: CGM markers - Tmax
timeFrame: From enrollment to day 30
measure: CGM markers - time in range (TIR)
timeFrame: From enrollment to day 30
measure: CGM markers - average interstitial glucose
timeFrame: From enrollment to day 30
measure: CGM markers - coefficient of variance (CV)
timeFrame: From enrollment to day 30
measure: CGM markers - mean amplitude of glycaemic excursion (MAGE)
timeFrame: From enrollment to day 30
Other outcomes:
measure: Long-term glucose metabolism -HbA1c
timeFrame: From day 0 to day 88
measure: International physical activity questionnaire
timeFrame: From enrollment to day 88
measure: Macronutrient and energy intake
timeFrame: From enrollment to day 88
measure: Actual changes in perceived change in lifestyle
timeFrame: From enrollment to day 88
measure: App usage - App screen time
timeFrame: From enrollment to day 30
measure: Long-term glucose metabolism -fasting plasma glucose
timeFrame: From day 0 to day 88
measure: Long-term glucose metabolism -insulin levels
timeFrame: From day 0 to day 88
measure: Long-term glucose metabolism -HOMA-IR
timeFrame: From day 0 to day 88
measure: lipid metabolism changes - HDL-C
timeFrame: From day 0 to day 88
measure: lipid metabolism changes - LDL-C
timeFrame: From day 0 to day 88
measure: lipid metabolism changes -Total cholesterol
timeFrame: From day 0 to day 88
measure: lipid metabolism changes - Triglycerides
timeFrame: From day 0 to day 88
measure: Weight outcomes changes - waist circumference
timeFrame: From day 0 to day 88
measure: Weight outcomes changes - BMI
timeFrame: From day 0 to day 88
measure: Weight outcomes changes - Body weight,
timeFrame: From day 0 to day 88
measure: App usage - numbers of log per days
timeFrame: From enrollment to day 30
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
Study officials:
References: