Effect of Fermented Maillard Reacted Whey Protein on Immune Function

The Immune-enhancing Effect of Supplementation With Fermented Maillard Reacted Whey Protein in Nondiabetic and Nonobese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Immune Deficiency
• Intervention / Treatment: Dietary supplement: Fermented Maillard reacted whey protein (F-MRP); Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group (F-MRP); Fermented Maillard reacted whey protein (F-MRP) supplementation	Dietary supplement: Fermented Maillard reacted whey protein (F-MRP); 6g of powder containing 4.2g fermented maillard reacted whey protein
Placebo Comparator: Placebo group; Placebo supplementation	Dietary supplement: Placebo; 6g of maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Natural killer cell activity	At baseline
Natural killer cell activity	At 8-week follow-up
Change from baseline natural killer cell activity at 8-week	At baseline and 8-week follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
White blood cell	At baseline
White blood cell	At 8-week follow-up
Change from baseline white blood cell at 8-week	At baseline and 8-week follow-up
Interleukin-12	At baseline
Interleukin-12	At 8-week follow-up
Change from baseline Interleukin-12 at 8-week	At baseline and 8-week follow-up
Interferon-gamma	At baseline
Interferon-gamma	At 8-week follow-up
Change from baseline Interferon-gamma at 8-week	At baseline and 8-week follow-up

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 4, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Interleukin-12; Immune function; Fermented Maillard reacted whey protein; Natural killer cell activity; Pre-albumin
• Additional Relevant MeSH Terms: Immune System Diseases; Immunologic Deficiency Syndromes
• Other Study ID Numbers: SU_immune