NCT04940910

Brief Summary

This study was conducted to investigate the efficacy and safety of Black rice bran extract on immune enhancement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 7, 2021

Last Update Submit

June 18, 2021

Conditions

Immunity

Keywords

Black Rice BranImmunity

Outcome Measures

Primary Outcomes (1)

  • Changes of Natural Killer cell activity

    Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 2.5:1, 5:1, 10:1. (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100

    baseline and 8 weeks

Secondary Outcomes (2)

  • Changes of Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha

    baseline and 8 weeks

  • Changes of Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21)

    baseline, 4 weeks and 8 weeks

Study Arms (2)

Black rice bran extract group

EXPERIMENTAL

2 times a day, 2 capsule for 1 time, after breakfast/dinner meal(1.52 g/day, Black rice bran extract 1 g/day)

Dietary Supplement: Black rice bran extract

Placebo group

PLACEBO COMPARATOR

2 times a day, 2 capsule for 1 time, after breakfast/dinner meal(1.52 g/day, Black rice bran extract 0 g/day)

Dietary Supplement: Placebo

Interventions

Black rice bran extractDIETARY_SUPPLEMENT

2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week

Black rice bran extract group
PlaceboDIETARY_SUPPLEMENT

2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week

Placebo group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men and women over 19 and under 75 years
  • After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

You may not qualify if:

  • If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
  • Those who received influenza vaccination within 3 months before first intake of intervention
  • Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
  • Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
  • Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
  • Those who have received antipsychotic medication within 3 months before screening
  • Those who alcoholic or drug abuse suspected
  • Those who participated in other clinical trials within 3 months before screening
  • Laboratory test by show the following results
  • Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  • Serum Creatinine \> 2.0 mg/dL
  • Pregnancy or breast feeding
  • Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
  • Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Central Study Contacts

Soo Wan Chae, Ph.D., M.D.

CONTACT

82-63-259-3040soowan@jbnu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 28, 2021

Study Start

February 22, 2021

Primary Completion

May 7, 2021

Study Completion

June 25, 2021

Last Updated

June 28, 2021

Record last verified: 2021-06

Locations

KR(1)