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

Primary Purpose

Healthy, PreDiabetes, Adult

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Blood collection

About this trial

This is an interventional basic science trial for Healthy focused on measuring Nestle, postprandial glucose, incretins, insulin, healthy

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
Known autoimmune and/or genetic disease
Known chronic diarrhea or gastrointestinal discomfort
Known endocrine and metabolic diseases under drug treatment (e.g., pituitary tumors, thyrotoxicosis due to various causes, Cushing's syndrome etc.)
Subjects on systemic corticosteroids, glucocorticoids, or cyclosporine A
Recent blood donation (<8 weeks)
Pregnant or lactating women

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

YIYANG TangLv milk powder

skimmed milk

Arm 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.

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

Outcomes

Primary Outcome Measures

3h-iAUC of PPGR

Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR)

Secondary Outcome Measures

iAUC of PPGR

Incremental area under the curve of PPGR (Postprandial Glucose Response)

Tmax of PPGR

Tmax(the time when Cmax is achieved) of PPGR (Postprandial Glucose Response)

Cmax of PPGR

Cmax(maximal value of measured timepoints) of PPGR (Postprandial Glucose Response)

iCmax of PPGR

iCmax( maximal incremental value ) of PPGR (Postprandial Glucose Response)

iAUC of PPIR

Incremental area under the curve of PPIR (Postprandial Insulin Response)

Tmax of PPIR

Tmax(the time when Cmax is achieved) of PPIR (Postprandial Insulin Response)

Cmax of PPIR

Cmax(maximal value of measured timepoints) of PPIR (Postprandial Insulin Response)

iCmax of PPIR

iCmax( maximal incremental value ) of PPIR (Postprandial Insulin Response)

Full Information

NCT ID

NCT05570435

First Posted

September 20, 2022

Last Updated

June 5, 2023

Sponsor

Société des Produits Nestlé (SPN)

Collaborators

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05570435

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

November 16, 2022 (Actual)

Primary Completion Date

March 14, 2023 (Actual)

Study Completion Date

March 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

Collaborators

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, PreDiabetes, Adult, Asian

Keywords

Nestle, postprandial glucose, incretins, insulin, healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YIYANG TangLv milk powder

Arm Type

Experimental

Arm Description

Arm Title

skimmed milk

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Blood collection

Intervention Description

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

Primary Outcome Measure Information:

Title

3h-iAUC of PPGR

Description

Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR)

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

iAUC of PPGR

Description

Incremental area under the curve of PPGR (Postprandial Glucose Response)

Time Frame

1hour, 2 hours

Title

Tmax of PPGR

Description

Tmax(the time when Cmax is achieved) of PPGR (Postprandial Glucose Response)

Time Frame

3 hours

Title

Cmax of PPGR

Description

Cmax(maximal value of measured timepoints) of PPGR (Postprandial Glucose Response)

Time Frame

3 hours

Title

iCmax of PPGR

Description

iCmax( maximal incremental value ) of PPGR (Postprandial Glucose Response)

Time Frame

3 hours

Title

iAUC of PPIR

Description

Incremental area under the curve of PPIR (Postprandial Insulin Response)

Time Frame

1 hour, 2 hours

Title

Tmax of PPIR

Description

Tmax(the time when Cmax is achieved) of PPIR (Postprandial Insulin Response)

Time Frame

3 hours

Title

Cmax of PPIR

Description

Cmax(maximal value of measured timepoints) of PPIR (Postprandial Insulin Response)

Time Frame

3 hours

Title

iCmax of PPIR

Description

iCmax( maximal incremental value ) of PPIR (Postprandial Insulin Response)

Time Frame

3 hours

Other Pre-specified Outcome Measures:

Title

additional endpoints slopes derived from PPGR

Description

additional endpoints slopes derived from PPGR

Time Frame

0, 15, 30 min or 1 hour, 2 hours, 3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Known autoimmune and/or genetic disease Known chronic diarrhea or gastrointestinal discomfort Known endocrine and metabolic diseases under drug treatment (e.g., pituitary tumors, thyrotoxicosis due to various causes, Cushing's syndrome etc.) Subjects on systemic corticosteroids, glucocorticoids, or cyclosporine A Recent blood donation (<8 weeks) Pregnant or lactating women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Chen

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

Country

China

12. IPD Sharing Statement

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

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