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Completed

NCT Number: NCT02895204

Effect of Fermented Maillard Reacted Whey Protein on Immune Function

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.

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Key information

Conditions

Immune Deficiency Immune System Diseases Immunologic Deficiency Syndromes

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented Maillard reacted whey protein (F-MRP)

Dietary Supplement

6g of powder containing 4.2g fermented maillard reacted whey protein

Placebo

Dietary Supplement

6g of maltodextrin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2016
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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