Immune Benefits of Consumption of Dairy Yogurt in Elderly

Immune Deficiency Clinical Trial

Official title:

Immune Benefits of Consumption of Dairy Yogurt Containing Functional Probiotics Among Individuals Over 60 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051425
• Other study ID #: CI_immune
• Status: Completed
• Phase: N/A
• First received: February 9, 2017
• Last updated: February 9, 2017
• Start date: March 28, 2016
• Est. completion date: February 8, 2017

Study information

• Verified date: February 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 8, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Deficiency
• Immunologic Deficiency Syndromes

Intervention

Dietary Supplement:
• Probiotic yogurt
120 mL of Yogurt containing Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus, Lactobacillus casei, Bifidobacterium animalis ssp. lactis, and Lactobacillus plantarum
• Placebo
120 mL of low-fat milk

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 12-week follow-up
Primary	Change from baseline natural killer cell activity at 12-week		At baseline and 12-week follow-up
Secondary	White blood cell		At baseline
Secondary	White blood cell		At 12-week follow-up
Secondary	Change from baseline white blood cell at 12-week		At baseline and 12-week follow-up
Secondary	Interleukin-12		At baseline
Secondary	Interleukin-12		At 12-week follow-up
Secondary	Change from baseline Interleukin-12 at 12-week		At baseline and 12-week follow-up
Secondary	Interferon-gamma		At baseline
Secondary	Interferon-gamma		At 12-week follow-up
Secondary	Change from baseline Interferon-gamma at 12-week		At baseline and 12-week follow-up
Secondary	Immunoglobulin		At baseline
Secondary	Immunoglobulin		At 12-week follow-up
Secondary	Change from baseline immunoglobulin at 12-week		At baseline and 12-week follow-up