NCT02895204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

February 13, 2017

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

August 30, 2016

Last Update Submit

February 9, 2017

Conditions

Immune Deficiency

Keywords

Fermented Maillard reacted whey proteinNatural killer cell activityImmune functionPre-albuminInterleukin-12

Outcome Measures

Primary Outcomes (3)

  • Natural killer cell activity

    At baseline

  • Natural killer cell activity

    At 8-week follow-up

  • Change from baseline natural killer cell activity at 8-week

    At baseline and 8-week follow-up

Secondary Outcomes (9)

  • White blood cell

    At baseline

  • White blood cell

    At 8-week follow-up

  • Change from baseline white blood cell at 8-week

    At baseline and 8-week follow-up

  • Interleukin-12

    At baseline

  • Interleukin-12

    At 8-week follow-up

  • +4 more secondary outcomes

Study Arms (2)

Test group (F-MRP)

EXPERIMENTAL

Fermented Maillard reacted whey protein (F-MRP) supplementation

Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP)

Placebo group

PLACEBO COMPARATOR

Placebo supplementation

Dietary Supplement: Placebo

Interventions

Fermented Maillard reacted whey protein (F-MRP)DIETARY_SUPPLEMENT

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

Test group (F-MRP)
PlaceboDIETARY_SUPPLEMENT

6g of maltodextrin

Placebo group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent
  • The levels of white blood cells within range 3x10\^3/μL\~8x10\^3/μL
  • Males and females
  • years old
  • Without no severe complications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Jong Ho Lee, PhD

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 9, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 13, 2017

Record last verified: 2016-09

Locations

KR(1)