NCT02214173

Brief Summary

The purpose of this study is to investigate the effects of the nutritional supplement rice bran arabinoxylan compound (RBAC) on metabolic syndrome variables in persons living with HIV. The hypothesis is that there will be a significant improvement in metabolic syndrome and immune variables in HIV-positive participants in the intervention group compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

First Submitted

Initial submission to the registry

August 1, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

August 1, 2014

Last Update Submit

July 15, 2016

Conditions

Human Immunodeficiency Virus Infection

Keywords

HIV, BRM4, hydrolyzed rice bran, metabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Improvement in Metabolic Syndrome Markers

    Improvement in glucose, lipid profile, blood pressure, cluster of differentiation 4 (CD4), and cluster of differentiation 8 (CD8) values.

    3 months and 6 months

Study Arms (2)

rice bran arabinoxylan compound (RBAC)

EXPERIMENTAL

2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.

Dietary Supplement: rice bran arabinoxylan compound (RBAC)

placebo

PLACEBO COMPARATOR

2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.

Dietary Supplement: Placebo

Interventions

rice bran arabinoxylan compound (RBAC)DIETARY_SUPPLEMENT

2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.

rice bran arabinoxylan compound (RBAC)
PlaceboDIETARY_SUPPLEMENT

2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.

placebo

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older
  • Confirmed HIV infection
  • CD4 T cell counts \> 50/µl and \< 250/µl
  • On a stable ART regimen (e.g., Kaletra-based) before (≤6 months) and during the intervention
  • Planning to maintain current medication during the course of the intervention
  • Not on any lipid-lowering agents for a minimum of 3 months before the enrollment
  • Previous nutritional supplement usage of similar polysaccharide formula permitted, but current use must be stopped 2 weeks before and during trial
  • Interested in participating in a dietary supplement study
  • Willing to follow recommendations for participating in the study
  • Willing to not consume food, alcohol, caffeine, or stimulants (amphetamines) 12 hours before each assessment
  • Able to provide informed consent

You may not qualify if:

  • Currently enrolled in another research trial for similar investigative nutritional therapies
  • Known allergy to rice, rice bran, mushrooms, or related food products
  • Any gastrointestinal disorders that could lead to uncertain resorption of the study supplement
  • 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 chemotherapeutic agents
  • Multiple drug resistance
  • Current smoker
  • Severe anemia or other medical condition that will not permit a safe blood draw
  • A bleeding disorder
  • A terminal illness
  • Women who are pregnant or are attempting conception, especially in the presence of a history of recurrent spontaneous abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMetabolic Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • John E Lewis, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 12, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 18, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)