Effect of Fermented Maillard Reacted Whey Protein on Immune Function

NCT ID: NCT02895204

Last Updated: 2017-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Immune Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Test group (F-MRP)

Fermented Maillard reacted whey protein (F-MRP) supplementation

Group Type: EXPERIMENTAL

Fermented Maillard reacted whey protein (F-MRP)

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

Placebo supplementation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

6g of maltodextrin

Interventions

Fermented Maillard reacted whey protein (F-MRP)

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

6g of maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong Ho Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Yonsei University

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SU_immune

Identifier Type: -

Identifier Source: org_study_id