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Effect of Fermented Maillard Reacted Whey Protein on Immune Function

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Yonsei University

Status

Completed

Conditions

Immune Deficiency

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP)

Study type

Interventional

Funder types

Other

Identifiers

NCT02895204
SU_immune

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

Test group (F-MRP)
Experimental group
Description:
Fermented Maillard reacted whey protein (F-MRP) supplementation
Treatment:
Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP)
Placebo group
Placebo Comparator group
Description:
Placebo supplementation
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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