NCT03051425

Brief Summary

To investigate the impact of consuming dairy yogurt on immun function including natural killer (NK) cell activity, circulating levels of cytokines, and immunoglobulin (Ig) in elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

February 9, 2017

Last Update Submit

February 9, 2017

Conditions

Keywords

ProbioticsImmune functionNatural killer cell activityInterleukin-12Interferon-gammaImmunoglobulin

Outcome Measures

Primary Outcomes (3)

  • Natural killer cell activity

    At baseline

  • Natural killer cell activity

    At 12-week follow-up

  • Change from baseline natural killer cell activity at 12-week

    At baseline and 12-week follow-up

Secondary Outcomes (12)

  • White blood cell

    At baseline

  • White blood cell

    At 12-week follow-up

  • Change from baseline white blood cell at 12-week

    At baseline and 12-week follow-up

  • Interleukin-12

    At baseline

  • Interleukin-12

    At 12-week follow-up

  • +7 more secondary outcomes

Study Arms (2)

Test group

EXPERIMENTAL

Probiotic yogurt supplementation

Dietary Supplement: Probiotic yogurt

Placebo group

PLACEBO COMPARATOR

Placebo supplementation

Dietary Supplement: Placebo

Interventions

Probiotic yogurtDIETARY_SUPPLEMENT

120 mL of Yogurt containing Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus, Lactobacillus casei, Bifidobacterium animalis ssp. lactis, and Lactobacillus plantarum

Test group
PlaceboDIETARY_SUPPLEMENT

120 mL of low-fat milk

Placebo group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent
  • Over 60 years old without any health problems
  • The levels of white blood cells within range 4x10\^3/μL\~10x10\^3/μL

You may not qualify if:

  • Individuals who get a cold
  • Diabetes
  • Hypersensitivity or disease history for milk protein
  • Epilepsy, neurological, or psychological disease
  • Alcoholism or drug addiction
  • Liver disease or severe kidney failure disease
  • Inflammation-related disease
  • Consumption of other test products or drugs within 1 month prior to screening
  • Regular consumption of immune-related functional foods including yogurt or milk within 1 month prior to screening
  • History of inflammation-related disease or taking medication to treat inflammation-related disease within 1 month prior to screening
  • History of cancer within 5 years
  • Any inappropriate condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University

Seoul, 03722, South Korea

Location

Related Publications (1)

  • Lee A, Lee YJ, Yoo HJ, Kim M, Chang Y, Lee DS, Lee JH. Consumption of Dairy Yogurt Containing Lactobacillus paracasei ssp. paracasei, Bifidobacterium animalis ssp. lactis and Heat-Treated Lactobacillus plantarum Improves Immune Function Including Natural Killer Cell Activity. Nutrients. 2017 May 31;9(6):558. doi: 10.3390/nu9060558.

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Jong Ho Lee

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 13, 2017

Study Start

March 28, 2016

Primary Completion

January 10, 2017

Study Completion

February 8, 2017

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations