Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response

Nestlé

Status: Completed

Conditions: Healthy; Adult; Asian; PreDiabetes

Treatments: Biological: Blood collection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05570435

21.16.NR

Details and patient eligibility

About

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.

Full description

This is an acute, monocentric, open label, randomized, 2-arm, cross-over, clinical trial in 30 subjects of Chinese Han ethnicity. Subjects will receive the two different interventions in a randomized order. This study will assess the efficacy of the investigational product after a single consumption. Day before (V1 and V3) the intervention visits (V2 and V4) the subjects will be admitted at the investigational site for an overnight stay where they will consume a standardized dinner. V2 and V3 will be followed by a wash-out period of 3 days. The two arms are:

Arm 1: skimmed milk (control) Arm 2: Nestle YIYANG TangLv milk powder

Enrollment: 31 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Willing and able to sign written informed consent prior to trial entry
2. Deemed able to comply with study protocol for 2-3 weeks
3. Male or female aged 45-75 years (inclusive 45 and 75)
4. HbA1c test results < 6.5% at Visit 1 (Admission 1)
5. Waist circumference ≤90 cm in males and ≤ 85 cm in females
6. Chinese Han ethnic group
7. BMI >18.5 and <28 kg/m2

Exclusion criteria

1. 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)
2. Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments
3. 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
4. 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
5. Consumption of tobacco products, smoking or chewing tobacco
6. History of significant organ dysfunction or disease
7. Subjects with refractory hypertension, and patients with hypertension who are taking antihypertensive drugs (beta-blockers, thiazide diuretics, etc.) that may affect blood glucose metabolism
8. 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
9. Known autoimmune and/or genetic disease
10. Known chronic diarrhea or gastrointestinal discomfort
11. Known endocrine and metabolic diseases under drug treatment (e.g., pituitary tumors, thyrotoxicosis due to various causes, Cushing's syndrome etc.)
12. Subjects on systemic corticosteroids, glucocorticoids, or cyclosporine A
13. Recent blood donation (<8 weeks)
14. Pregnant or lactating women

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

YIYANG TangLv milk powder

Experimental group

Description:

30g of milk powder (Nestle YIYANG TangLv milk powder) containing 789 mg Reducose® extract, standardized to contain 1% 1-deoxynojirimycin (1-DNJ), 10% of an oil mix and 8% of soluble fiber reconstituted with 180 ml of warm water.

Treatment:

Biological: Blood collection

skimmed milk

Active Comparator group

Description:

25g of commercially available skimmed milk powder reconstituted with 180 ml of warm water.

Treatment:

Biological: Blood collection