Effect of Fermented Maillard Reacted Whey Protein on Immune Function

Immune Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895204
• Other study ID #: SU_immune
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: February 9, 2017
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Deficiency
• Immunologic Deficiency Syndromes

Intervention

Dietary Supplement:
• Fermented Maillard reacted whey protein (F-MRP)
6g of powder containing 4.2g fermented maillard reacted whey protein
• Placebo
6g of maltodextrin

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural killer cell activity		At baseline
Primary	Natural killer cell activity		At 8-week follow-up
Primary	Change from baseline natural killer cell activity at 8-week		At baseline and 8-week follow-up
Secondary	White blood cell		At baseline
Secondary	White blood cell		At 8-week follow-up
Secondary	Change from baseline white blood cell at 8-week		At baseline and 8-week follow-up
Secondary	Interleukin-12		At baseline
Secondary	Interleukin-12		At 8-week follow-up
Secondary	Change from baseline Interleukin-12 at 8-week		At baseline and 8-week follow-up
Secondary	Interferon-gamma		At baseline
Secondary	Interferon-gamma		At 8-week follow-up
Secondary	Change from baseline Interferon-gamma at 8-week		At baseline and 8-week follow-up