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Effect of Fermented Maillard Reacted Whey Protein on Immune Function

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ClinicalTrials.gov Identifier: NCT02895204
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Natural killer cell activity [ Time Frame: At baseline ]
  2. Natural killer cell activity [ Time Frame: At 8-week follow-up ]
  3. Change from baseline natural killer cell activity at 8-week [ Time Frame: At baseline and 8-week follow-up ]

Secondary Outcome Measures :
  1. White blood cell [ Time Frame: At baseline ]
  2. White blood cell [ Time Frame: At 8-week follow-up ]
  3. Change from baseline white blood cell at 8-week [ Time Frame: At baseline and 8-week follow-up ]
  4. Interleukin-12 [ Time Frame: At baseline ]
  5. Interleukin-12 [ Time Frame: At 8-week follow-up ]
  6. Change from baseline Interleukin-12 at 8-week [ Time Frame: At baseline and 8-week follow-up ]
  7. Interferon-gamma [ Time Frame: At baseline ]
  8. Interferon-gamma [ Time Frame: At 8-week follow-up ]
  9. Change from baseline Interferon-gamma at 8-week [ Time Frame: At baseline and 8-week follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895204


Locations
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Korea, Republic of
Yonsei University
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Jong Ho Lee, PhD Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02895204     History of Changes
Other Study ID Numbers: SU_immune
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: September 2016
Keywords provided by Yonsei University:
Fermented Maillard reacted whey protein
Natural killer cell activity
Immune function
Pre-albumin
Interleukin-12
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases