Effect of Fermented Maillard Reacted Whey Protein on Immune Function

Yonsei University80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Immune Deficiency

Interventions

Fermented Maillard reacted whey protein (F-MRP)DIETARY_SUPPLEMENT

6g of powder containing 4.2g fermented maillard reacted whey protein

PlaceboDIETARY_SUPPLEMENT

6g of maltodextrin

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Yonsei University

Seoul, South Korea

Outcomes

Primary Outcomes

Natural killer cell activity

Time frame: At baseline

Natural killer cell activity

Time frame: At 8-week follow-up

Change from baseline natural killer cell activity at 8-week

Time frame: At baseline and 8-week follow-up

Secondary Outcomes

White blood cell

Time frame: At baseline

White blood cell

Time frame: At 8-week follow-up

Change from baseline white blood cell at 8-week

Time frame: At baseline and 8-week follow-up

Interleukin-12

Time frame: At baseline

Interleukin-12

Time frame: At 8-week follow-up

Change from baseline Interleukin-12 at 8-week

Time frame: At baseline and 8-week follow-up

Interferon-gamma

Time frame: At baseline

Interferon-gamma

Time frame: At 8-week follow-up

Change from baseline Interferon-gamma at 8-week

Time frame: At baseline and 8-week follow-up

Data from ClinicalTrials.gov

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