Effect of Visualization of Functional Milk Efficacy on Perceived Benefits

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how visualizing the effects of drinking a special type of milk can influence people's perceptions of its benefits, especially concerning their blood sugar levels after eating. The trial is open to healthy adults between the ages of 45 and 75 who are not diabetic but may be at risk for prediabetes. To qualify, participants should have a body mass index (BMI) between 18.5 and 35, regularly eat a carbohydrate-rich breakfast, and lead a mostly sedentary lifestyle, meaning they don’t exercise vigorously.

If you decide to join the study, you’ll need to sign a consent form and follow the study guidelines, which include avoiding vigorous physical activity during the trial. You will consume the special milk and report your experiences. It’s important to note that certain medical conditions, allergies, or lifestyle factors may disqualify you from participating, such as having diabetes, significant weight loss recently, or being on specific medications. This study is currently recruiting participants, so it’s a chance to contribute to research that may help understand dietary impacts on health.

Gender

ALL

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.