Clinical trial NCT02895204: Effect of Fermented Maillard Reacted Whey Protein on Immune Function
Official title: The Immune-enhancing Effect of Supplementation With Fermented Maillard Reacted Whey Protein in Nondiabetic and Nonobese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Deficiency
Keywords: Fermented Maillard reacted whey protein
Natural killer cell activity
Immune function
Pre-albumin
Interleukin-12
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Natural killer cell activity
timeFrame: At baseline
measure: Natural killer cell activity
timeFrame: At 8-week follow-up
measure: Change from baseline natural killer cell activity at 8-week
timeFrame: At baseline and 8-week follow-up
Secondary outcomes:
measure: White blood cell
timeFrame: At baseline
measure: White blood cell
timeFrame: At 8-week follow-up
measure: Change from baseline white blood cell at 8-week
timeFrame: At baseline and 8-week follow-up
measure: Interleukin-12
timeFrame: At baseline
measure: Interleukin-12
timeFrame: At 8-week follow-up
measure: Change from baseline Interleukin-12 at 8-week
timeFrame: At baseline and 8-week follow-up
measure: Interferon-gamma
timeFrame: At baseline
measure: Interferon-gamma
timeFrame: At 8-week follow-up
measure: Change from baseline Interferon-gamma at 8-week
timeFrame: At baseline and 8-week follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: