NCT03209635

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

12 months

First QC Date

July 4, 2017

Last Update Submit

July 4, 2017

Conditions

Immune Function

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Probiotic

EXPERIMENTAL

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

Interventions

PlaceboDIETARY_SUPPLEMENT

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

Placebo
ProbioticDIETARY_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

Probiotic

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jong Ho Lee, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 6, 2017

Study Start

April 1, 2016

Primary Completion

March 20, 2017

Study Completion

March 20, 2017

Last Updated

July 6, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share