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OpenTrials
Completed

NCT Number: NCT03051425

Immune Benefits of Consumption of Dairy Yogurt in Elderly

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.

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Key information

Conditions

Immune Deficiency Immune System Diseases Immunologic Deficiency Syndromes

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic yogurt

Dietary Supplement

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

Placebo

Dietary Supplement

120 mL of low-fat milk

Primary outcomes

  1. Natural killer cell activity

    Time frame: At baseline

  2. Natural killer cell activity

    Time frame: At 12-week follow-up

  3. Change from baseline natural killer cell activity at 12-week

    Time frame: At baseline and 12-week follow-up

Secondary outcomes

  1. White blood cell

    Time frame: At baseline

  2. White blood cell

    Time frame: At 12-week follow-up

  3. Change from baseline white blood cell at 12-week

    Time frame: At baseline and 12-week follow-up

  4. Interleukin-12

    Time frame: At baseline

  5. Interleukin-12

    Time frame: At 12-week follow-up

  6. Change from baseline Interleukin-12 at 12-week

    Time frame: At baseline and 12-week follow-up

  7. Interferon-gamma

    Time frame: At baseline

  8. Interferon-gamma

    Time frame: At 12-week follow-up

  9. Change from baseline Interferon-gamma at 12-week

    Time frame: At baseline and 12-week follow-up

  10. Immunoglobulin

    Time frame: At baseline

  11. Immunoglobulin

    Time frame: At 12-week follow-up

  12. Change from baseline immunoglobulin at 12-week

    Time frame: At baseline and 12-week follow-up

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2017
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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