Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response (NCT05570435) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response
China31 participantsStarted 2022-11-16
Plain-language 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.
Who can participate
Age range45 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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