NCT02019628

Brief Summary

The present study investigated the effect of RBAC on natural killer cell activity (NKCA) and the production of cytokines and growth factors over 4 weeks among healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

December 18, 2013

Last Update Submit

October 6, 2023

Conditions

Family Member

Keywords

NK cells cytotoxicity, dietary supplementation

Outcome Measures

Primary Outcomes (2)

  • Immune Functioning - NK Cell activity

    NK Cell activity at baseline, 48 hours, 1 week, 1 month, and 2 months.

    60 days

  • Immune Functioning - Cytokines

    Cytokines at baseline, 1 month, and 2 months.

    60 days

Secondary Outcomes (9)

  • Bilirubin

    60 days

  • Blood Pressure and Heart Rate

    60 days

  • Physical Activity

    60 days

  • Functional Health and Well-being

    60 days

  • Creatinine

    60 days

  • +4 more secondary outcomes

Study Arms (2)

BRM4 at a dosage level of 1 gram/day

EXPERIMENTAL

60-day trial of Rice Bran Arabinoxylan Compound (RBAC) at a dosage level of 1 gram/day.

Dietary Supplement: Rice Bran Arabinoxylan Compound (RBAC)

BRM4 at a dosage level of 3 grams/day

EXPERIMENTAL

60-day trial of Rice Bran Arabinoxylan Compound (RBAC) at a dosage level of 3 grams/day.

Dietary Supplement: Rice Bran Arabinoxylan Compound (RBAC)

Interventions

Rice Bran Arabinoxylan Compound (RBAC)DIETARY_SUPPLEMENT

Participants enrolled in the study will receive BRM4 at a dosage level of either 1 gram/day or 3 gram/day for the 60-day period. Subjects will be instructed to not consume any known immune-active pharmaceutical agents, nutritional supplements containing vitamins C and D, and/or any mushroom products for two weeks prior to having the baseline assessments and until the conclusion of the 60-day period. According to the company's literature, RBAC is a water soluble extract of rice bran that has been acted upon by an enzyme complex extracted from Shiitake mushroom. BRM4 contains: microcrystalline cellulose, hypromellose, sucrose fatty acid ester, gellan gum, and potassium acetate.

BRM4 at a dosage level of 1 gram/dayBRM4 at a dosage level of 3 grams/day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men ages 18 years and over.
  • Interest in participating in a novel nutritional supplement program.
  • Willingness to follow recommendations.

You may not qualify if:

  • Currently enrolled in another research trial for investigative nutritional or other therapies thought to have an impact on immune system functioning.
  • Unable to consent to the study.
  • Women who are pregnant or are attempting conception, especially in the presence of a history of recurrent spontaneous abortion.
  • Other medical complications that might preclude one from participating in the study, i.e., recent heart attack or stroke or chronic kidney disease.
  • Currently taking immunomodulatory medication, i.e. interferon.
  • Currently taking other medications thought to have an impact on immune system functioning, i.e., chemotherapeutic agents.
  • Known allergy to rice, rice bran, or related food products.
  • Known allergy to mushrooms or related food products.
  • History of malignancies related to the NK cell line, including: NK cell leukemias and T-cell large granular lymphocyte leukemias, NK-cell lymphoproliferative disease of granular lymphocytes, and NK cell lymphomas, e.g., nasal and nasal-like NK/T-cell lymphomas.
  • Current smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami CRB

Miami, Florida, 33136, United States

Location

Study Officials

  • John E. Lewis, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 24, 2013

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

November 1, 2011

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

US(1)