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Completed

NCT Number: NCT03209635

Weissella Cibaria JW15 Consumption and NK Cell Activity

A The aim of this study was to investigate the impact of consuming Weissella cibaria (W. cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin (Ig).

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Key information

Conditions

Immune Function

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A randomized, double-blinded, placebo-controlled study was conducted on 100 nondiabetic subjects. Over an eight-week testing period, the probiotic group consumed 4 capsules (300 mg/capsule) containing 1 x 10^10 colony-forming units (cfu) of W. cibaria JW15 each day, whereas the placebo group consumed the same product without a probiotic.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Nondiabetic (fasting serum glucose concentration < 126 mg/dL)
  • Subjects with 4,000-8,000 leukocyte counts

Exclusion criteria

  • Constant consumption of any probiotic products
  • Taking medicine related to inflammation within one month before screening
  • Allergy to probiotics
  • Lactose intolerance
  • Diabetes
  • History/presence of significant metabolic disease
  • Acute or chronic disease requiring treatment
  • Taking any medications

Treatment and study plan

Placebo

Dietary Supplement

4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product

Probiotic

Dietary Supplement

4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day

Primary outcomes

  1. Natural killer cell activity at baseline

    Time frame: Baseline

    Natural killer cell activity (%)

  2. Natural killer cell activity at 8-week follow up

    Time frame: 8-week follow up

    Natural killer cell activity (%)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2017
Registry last updated
Jul 6, 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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