Effect of Fermented Maillard Reacted Whey Protein on Immune Function

Not Applicable

Completed

• Conditions: Immune Deficiency
• Interventions: Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP); Dietary Supplement: Placebo

• Registration Number: NCT02895204
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-08-30
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group (F-MRP)	Fermented Maillard reacted whey protein (F-MRP)	Fermented Maillard reacted whey protein (F-MRP) supplementation
Placebo group	Placebo	Placebo supplementation

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of