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Effect of Fermented Maillard Reacted Whey Protein on Immune Function

Primary Purpose

Immune Deficiency

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fermented Maillard reacted whey protein (F-MRP)
Placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Immune Deficiency focused on measuring Fermented Maillard reacted whey protein, Natural killer cell activity, Immune function, Pre-albumin, Interleukin-12

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to give informed consent
  • The levels of white blood cells within range 3x10^3/μL~8x10^3/μL
  • Males and females
  • 20-70 years old
  • Without no severe complications

Exclusion Criteria:

  • Diabetes
  • White blood cell under 3x10^3/μL or over 8x10^3/μL
  • Pregnancy or breast-feeding
  • Hypersensitivity or disease history for milk protein
  • Liver disease, inflammation disease, or severe kidney failure disease
  • Cancer, lung disease, leukemia, or autoimmune disease
  • Psychological or neurological disease
  • Myocardiac infarction or cerebrovascular diseases within 6 months before screening
  • Consumption of other test products or drugs within 1 month before screening
  • Inflammation related disease within 1 month before screening

Sites / Locations

  • Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group (F-MRP)

Placebo group

Arm Description

Fermented Maillard reacted whey protein (F-MRP) supplementation

Placebo supplementation

Outcomes

Primary Outcome Measures

Natural killer cell activity
Natural killer cell activity
Change from baseline natural killer cell activity at 8-week

Secondary Outcome Measures

White blood cell
White blood cell
Change from baseline white blood cell at 8-week
Interleukin-12
Interleukin-12
Change from baseline Interleukin-12 at 8-week
Interferon-gamma
Interferon-gamma
Change from baseline Interferon-gamma at 8-week

Full Information

First Posted
August 30, 2016
Last Updated
February 9, 2017
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02895204
Brief Title
Effect of Fermented Maillard Reacted Whey Protein on Immune Function
Official Title
The Immune-enhancing Effect of Supplementation With Fermented Maillard Reacted Whey Protein in Nondiabetic and Nonobese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

5. Study Description

Brief Summary
To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on natural killer (NK) cell activity, circulating cytokines and serum protein levels.
Detailed Description
A randomized, double-blind, placebo-controlled study was conducted on 80 participant without diabetes and obesity. Over a 8-week testing period, the F-MRP group consumed 6 g of powder containing 4.2 g F-MRP each day, whereas the placebo group consumed the same amount with dextrin. NK cell activity (%) was measured based on the ratios of effector cells (E; peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562 cells) at E:T= 10:1, 5:1, 2.5:1, or 1.25:1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Deficiency
Keywords
Fermented Maillard reacted whey protein, Natural killer cell activity, Immune function, Pre-albumin, Interleukin-12

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group (F-MRP)
Arm Type
Experimental
Arm Description
Fermented Maillard reacted whey protein (F-MRP) supplementation
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Fermented Maillard reacted whey protein (F-MRP)
Intervention Description
6g of powder containing 4.2g fermented maillard reacted whey protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
6g of maltodextrin
Primary Outcome Measure Information:
Title
Natural killer cell activity
Time Frame
At baseline
Title
Natural killer cell activity
Time Frame
At 8-week follow-up
Title
Change from baseline natural killer cell activity at 8-week
Time Frame
At baseline and 8-week follow-up
Secondary Outcome Measure Information:
Title
White blood cell
Time Frame
At baseline
Title
White blood cell
Time Frame
At 8-week follow-up
Title
Change from baseline white blood cell at 8-week
Time Frame
At baseline and 8-week follow-up
Title
Interleukin-12
Time Frame
At baseline
Title
Interleukin-12
Time Frame
At 8-week follow-up
Title
Change from baseline Interleukin-12 at 8-week
Time Frame
At baseline and 8-week follow-up
Title
Interferon-gamma
Time Frame
At baseline
Title
Interferon-gamma
Time Frame
At 8-week follow-up
Title
Change from baseline Interferon-gamma at 8-week
Time Frame
At baseline and 8-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to give informed consent The levels of white blood cells within range 3x10^3/μL~8x10^3/μL Males and females 20-70 years old Without no severe complications Exclusion Criteria: Diabetes White blood cell under 3x10^3/μL or over 8x10^3/μL Pregnancy or breast-feeding Hypersensitivity or disease history for milk protein Liver disease, inflammation disease, or severe kidney failure disease Cancer, lung disease, leukemia, or autoimmune disease Psychological or neurological disease Myocardiac infarction or cerebrovascular diseases within 6 months before screening Consumption of other test products or drugs within 1 month before screening Inflammation related disease within 1 month before screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Lee, PhD
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Fermented Maillard Reacted Whey Protein on Immune Function

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