Weissella Cibaria JW15 Consumption and NK Cell Activity

NCT ID: NCT03209635

Last Updated: 2017-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-03-20

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Immune Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Probiotic

Intervention Type 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

Interventions

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Placebo

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Jong Ho Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Ho Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Food and Nutrition, Colleage of Human Ecology, Yonsei University

Other Identifiers

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AI_probiotic_NK

Identifier Type: -

Identifier Source: org_study_id

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