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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

Tracking Information
First Submitted Date  ICMJE August 30, 2016
First Posted Date  ICMJE September 9, 2016
Last Update Posted Date February 13, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2016)
  • Natural killer cell activity [ Time Frame: At baseline ]
  • Natural killer cell activity [ Time Frame: At 8-week follow-up ]
  • Change from baseline natural killer cell activity at 8-week [ Time Frame: At baseline and 8-week follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02895204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2016)
  • White blood cell [ Time Frame: At baseline ]
  • White blood cell [ Time Frame: At 8-week follow-up ]
  • Change from baseline white blood cell at 8-week [ Time Frame: At baseline and 8-week follow-up ]
  • Interleukin-12 [ Time Frame: At baseline ]
  • Interleukin-12 [ Time Frame: At 8-week follow-up ]
  • Change from baseline Interleukin-12 at 8-week [ Time Frame: At baseline and 8-week follow-up ]
  • Interferon-gamma [ Time Frame: At baseline ]
  • Interferon-gamma [ Time Frame: At 8-week follow-up ]
  • Change from baseline Interferon-gamma at 8-week [ Time Frame: At baseline and 8-week follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fermented Maillard Reacted Whey Protein on Immune Function
Official Title  ICMJE The Immune-enhancing Effect of Supplementation With Fermented Maillard Reacted Whey Protein in Nondiabetic and Nonobese Subjects
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Immune Deficiency
Intervention  ICMJE
  • Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP)
    6g of powder containing 4.2g fermented maillard reacted whey protein
  • Dietary Supplement: Placebo
    6g of maltodextrin
Study Arms  ICMJE
  • Experimental: Test group (F-MRP)
    Fermented Maillard reacted whey protein (F-MRP) supplementation
    Intervention: Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP)
  • Placebo Comparator: Placebo group
    Placebo supplementation
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2016)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02895204
Other Study ID Numbers  ICMJE SU_immune
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jong Ho Lee, PhD Yonsei University
PRS Account Yonsei University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP