Weissella Cibaria JW15 Consumption and NK Cell Activity

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03209635
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Actual Duration (Months): 11.6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Immune Function	Dietary Supplement: Placebo; Dietary Supplement: Probiotic	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Weissella Cibaria JW15 Consumption and NK Cell Activity
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Mar 20, 2017
• Actual Study Completion Date: Mar 20, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Natural killer cell activity at baseline [Baseline]

   Natural killer cell activity (%)

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

   Natural killer cell activity (%)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jong Ho Lee, Professor, Yonsei University
• ClinicalTrials.gov Identifier: NCT03209635
• Other Study ID Numbers: AI_probiotic_NK
• First Posted: Jul 6, 2017
• Last Update Posted: Jul 6, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 6, 2017