Clinical trial NCT03051425: Immune Benefits of Consumption of Dairy Yogurt in Elderly
Official title: Immune Benefits of Consumption of Dairy Yogurt Containing Functional Probiotics Among Individuals Over 60 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Deficiency
Keywords: Probiotics
Immune function
Natural killer cell activity
Interleukin-12
Interferon-gamma
Immunoglobulin
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 60
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 consuming dairy yogurt on immun function including natural killer (NK) cell activity, circulating levels of cytokines, and immunoglobulin (Ig) in elderly.

Detailed description: A randomized, open-labelled, placebo-controlled study was conducted on 200 nondiabetic, nonobese and elderly (≥60 years) subjects. Over a twelve-week period, the test group consumed one bottle (120 mL) of dairy yogurt each day, whereas the placebo group consumed same volume of low fat milk daily. 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, 1.25:1 or 0.625:1. In addition, cytokines and immunoglobulin levels measured using commercial kits as manufacturer's instruction.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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