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

Healthy Clinical Trial

Official title:

Evaluate Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response: an Acute Study in Chinese Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05570435
• Other study ID #: 21.16.NR
• Status: Completed
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: March 14, 2023

Study information

• Verified date: June 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult
• Healthy
• PreDiabetes
• Prediabetic State

Intervention

Biological:
• Blood collection
Blood collection for glucose, insulin, GLP-1, GIP and C-peptide.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	additional endpoints slopes derived from PPGR	additional endpoints slopes derived from PPGR	0, 15, 30 min or 1 hour, 2 hours, 3 hours
Primary	3h-iAUC of PPGR	Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR)	3 hours
Secondary	iAUC of PPGR	Incremental area under the curve of PPGR (Postprandial Glucose Response)	1hour, 2 hours
Secondary	Tmax of PPGR	Tmax(the time when Cmax is achieved) of PPGR (Postprandial Glucose Response)	3 hours
Secondary	Cmax of PPGR	Cmax(maximal value of measured timepoints) of PPGR (Postprandial Glucose Response)	3 hours
Secondary	iCmax of PPGR	iCmax( maximal incremental value ) of PPGR (Postprandial Glucose Response)	3 hours
Secondary	iAUC of PPIR	Incremental area under the curve of PPIR (Postprandial Insulin Response)	1 hour, 2 hours
Secondary	Tmax of PPIR	Tmax(the time when Cmax is achieved) of PPIR (Postprandial Insulin Response)	3 hours
Secondary	Cmax of PPIR	Cmax(maximal value of measured timepoints) of PPIR (Postprandial Insulin Response)	3 hours
Secondary	iCmax of PPIR	iCmax( maximal incremental value ) of PPIR (Postprandial Insulin Response)	3 hours