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).

Study Overview

• Status: Completed
• Conditions: Immune Function
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product	Dietary supplement: Placebo; 4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product
Experimental: 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	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natural killer cell activity at baseline	Natural killer cell activity (%)	Baseline
Natural killer cell activity at 8-week follow up	Natural killer cell activity (%)	8-week follow up

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Jong Ho Lee, Ph.D., Dept. of Food and Nutrition, Colleage of Human Ecology, Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 20, 2017
• Study Completion (Actual): March 20, 2017

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 4, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AI_probiotic_NK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No