Effect of Fermented Maillard Reacted Whey Protein on Immune Function

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Immune Deficiency

Intervention / Treatment
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* Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fermented Maillard reacted whey protein, Natural killer cell activity, Immune function, Pre-albumin, Interleukin-12