Clinical trial NCT05570435: Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response
Official title: Evaluate Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response: an Acute Study in Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
PreDiabetes
Adult
Asian
Keywords: Nestle, postprandial glucose, incretins, insulin, healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
First posted: 2022-10-06
Enrollment: 31
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: 3h-iAUC of PPGR
timeFrame: 3 hours
Secondary outcomes:
measure: iAUC of PPGR
timeFrame: 1hour, 2 hours
measure: Tmax of PPGR
timeFrame: 3 hours
measure: Cmax of PPGR
timeFrame: 3 hours
measure: iCmax of PPGR
timeFrame: 3 hours
measure: iAUC of PPIR
timeFrame: 1 hour, 2 hours
measure: Tmax of PPIR
timeFrame: 3 hours
measure: Cmax of PPIR
timeFrame: 3 hours
measure: iCmax of PPIR
timeFrame: 3 hours
Other outcomes:
measure: additional endpoints slopes derived from PPGR
timeFrame: 0, 15, 30 min or 1 hour, 2 hours, 3 hours
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wei Chen
role: PRINCIPAL_INVESTIGATOR
References: