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
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
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
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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