Effect of Fermented Maillard Reacted Whey Protein on Immune Function

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02895204

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Deficiency	Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP) Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Able to give informed consent
The levels of white blood cells within range 3x10^3/μL~8x103/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