Weissella Cibaria JW15 Consumption and NK Cell Activity

Immune Function Clinical Trial

Official title:

Weissella Cibaria JW15 Consumption and NK Cell Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209635
• Other study ID #: AI_probiotic_NK
• Status: Completed
• Phase: N/A
• First received: July 4, 2017
• Last updated: July 4, 2017
• Start date: April 1, 2016
• Est. completion date: March 20, 2017

Study information

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

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Function

Intervention

Dietary Supplement:
• Placebo
4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product
• Probiotic
4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural killer cell activity at baseline	Natural killer cell activity (%)	Baseline
Primary	Natural killer cell activity at 8-week follow up	Natural killer cell activity (%)	8-week follow up