Inflammation in HIV InfectionBRM4NCT02922907
Rice Bran Supplementation in Treated HIV Infection
A study testing arabinoxylan rice bran in people with Inflammation in HIV Infection, run by University of Southern California at 1 site in United States.
Trial summary
Double-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation in HIV Infection
- What is being tested?
- arabinoxylan rice bran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2017to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV-1 infection
- Currently on a combination antiretroviral regimen for ≥24 weeks prior to study entry with no interruption longer than 7 consecutive days during that period.
- Plasma HIV-1 RNA levels below 50 copies/mL for at least 24 weeks prior to study entry.
- CD4+ cell count 100-350 cells/mm3 obtained within 90 days prior to study entry.
- The following laboratory values obtained within 90 days prior to entry by any US laboratory that has a CLIA certification or its equivalent.
- Absolute neutrophil count (ANC) ≥750/mm3
Show all 18Show fewer
- Hemoglobin ≥8.0 g/dL
- Platelet count ≥50,000/mm3
- Calculated creatinine clearance (CrCl) ≥50 mL/min as estimated by the Cockroft-Gault formula
- Aspartate aminotransferase (AST) (SGOT) ≤5 x upper limit of normal (ULN).
- alanine aminotransferase (ALT) (SGPT) ≤5 x ULN.
- alkaline phosphatase ≤5 x ULN.
- Total bilirubin ≤2.5 x ULN (if the participant is receiving atazanavir, a total bilirubin of ≤5 x ULN is acceptable)
- For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e. who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization (specifically hysterectomy or bilateral oophorectomy or tubal ligation), will require a negative serum or urine pregnancy test (latter with a sensitivity of 15-25 mIU/mL) within 2 days prior to entry.
- If participating in sexual activity that could lead to pregnancy, the female study volunteer must be willing to use a contraceptive while receiving protocol-specified medication
- Men and women age 18 years or greater.
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
- Participants on statin therapy must be stable on the same dose for at least the prior 12 weeks with no anticipated change in statin or dose during the intervention
Who cannot join
- Change in the ART regimen within the 12 weeks prior to study entry, or anticipated/intended modification of ART during the study period.
- Two or more HIV-1 RNA determinations >200 copies/mL within the 48 week period prior to study entry.
- Use of any immunomodulator, HIV vaccine, investigational therapy, or anti-TNF therapies within 90 days prior to study entry.
- Active malignancy with expected need for systemic chemotherapy or radiation therapy during the study period.
- Pregnant or breastfeeding.
- Known allergy/sensitivity to rice, rice bran, mushrooms, or related food products.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rand Schrader Health and Research Clinic
Los Angeles, California, 90033
About this study
Official title: Anti-Inflammatory Effects of Arabinoxylan Rice Bran Supplementation in Participants With Treated, Suppressed HIV Infection and Inadequate Immune Reconstitution
Double-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution.
Read the detailed description
Rationale: HIV infected persons have greater levels of inflammation and immune activation compared to the general population and are at greater risk of developing coronary heart disease (CHD) and other inflammation-associated co-morbidities. Intervention with BRM4 (Arabinoxylan Rice Bran Supplementation) in this population with impaired immune reconstitution may improve inflammation by a variety of mechanisms.
Intervention: Arabinoxylan Rice Bran Supplementation with BRM4, is a nutritional supplement marketed in the US. It is composed of dietary fiber obtained from a denatured hemicellulose that is obtained by reacting rice bran hemicellulose with multiple carbohydrate hydrolyzing enzymes from Shiitake mushrooms.
Objectives: The primary objective is to evaluate if 12 weeks of supplementation with arabinoxylan rice bran can safely reduce markers of inflammation during ART-suppressed HIV infection and thus potentially reduce the potential to develop end-organ disease in this group of at-risk patients.
Study population: HIV-infected participants (≥18 years of age) who have been on stable ART for at least 24 weeks prior to study entry, and have impaired immune reconstitution defined as a CD4+ T-cell count 100-350 cells/mm3 prior to study entry, with plasma HIV-1 RNA <50 copies/mL. In order to assure 24 evaluable subjects, the investigators will enroll 28 subjects total (assuming 15% lost to follow-up rate).
Study methodology: Randomized, double blind, placebo controlled clinical trial
Description of study arms: At entry participants will be randomized to one of the following arms:
Arm 1: BRM4 two 500mg capsules thrice daily p.o. for 12 weeks
Arm 2: Placebo for Biobran two capsules thrice daily p.o. for 12 weeks
Study endpoints: Primary - changes in sCD14 levels after 12 weeks of intervention. Secondary - week 12 changes in other inflammatory markers, microbial translocation, T-cell counts, and metabolic variables.
Follow-up: Participants will not be followed after study completion, unless follow-up is necessary for an adverse event.
Statistics: A total sample of 24 evaluable subjects (12 per arm) is needed to detect a clinically relevant difference of 0.07 log10 in sCD14 levels between treatment vs. placebo arms with 90% power and a 0.05 two-sided type I error rate.
Plans for analysis: For the primary analysis, changes in sCD14 (and other biomarkers) from baseline to week 12 will be compared between the treatment arm and the placebo arm by a two-sided, two-sample t-test.
- Conditions
- Inflammation in HIV Infection
- Being tested
- arabinoxylan rice bran, Placebo for arabinoxylan rice bran
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arabinoxylan rice branDietary supplement
Also called Biobran, BRM4
a proprietary product derived from rice bran treated with extracts from three mushrooms
Placebo for arabinoxylan rice branDietary supplement
inactive product
| Study group | Role | What they receive |
|---|---|---|
| Arabinoxylan Rice Bran | Experimental | BRM4 two 500mg capsules thrice daily p.o. for 12 weeks Receives: Dietary Supplement: arabinoxylan rice bran |
| Placebo | Placebo comparator | Placebo for BRM4 two 500mg capsules thrice daily p.o. for 12 weeks Receives: Dietary Supplement: Placebo for arabinoxylan rice bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in soluble CD14 levels will be compared between the supplement or placebo
Marker of macrophage activation
Measured: 12 weeks
Secondary outcomes (4)
Changes in LPS levels
measure of gut microbial translocation
Measured: 12 weeks
changes in hsCRP levels
inflammatory biomarker
Measured: 12 weeks
changes in D-dimer levels
coagulation biomarker
Measured: 12 weeks
changes in soluble CD163 levels
marker of macrophage activation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start24 Mar 2017
- Primary completion3 Dec 2018
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation in HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dube, University of Southern California
- Investigators
- Michael P Dubé, MD, Study director, University of Souther California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922907
- Sponsor's protocol ID
- HS-16-00428
- Acronym
- BRM4
- Status last verified
- Apr 2021
- First submitted
- 28 Sep 2016
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Effects of Arabinoxylan Rice Bran Supplementation in Participants With Treated, Suppressed HIV Infection and Inadequate Immune Reconstitution
- ClinicalTrials.gov ID
- NCT02922907
- Acronym / sponsor ID
- BRM4 / HS-16-00428
- Conditions
- Inflammation in HIV Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution.
Detailed description
Rationale: HIV infected persons have greater levels of inflammation and immune activation compared to the general population and are at greater risk of developing coronary heart disease (CHD) and other inflammation-associated co-morbidities. Intervention with BRM4 (Arabinoxylan Rice Bran Supplementation) in this population with impaired immune reconstitution may improve inflammation by a variety of mechanisms.
Intervention: Arabinoxylan Rice Bran Supplementation with BRM4, is a nutritional supplement marketed in the US. It is composed of dietary fiber obtained from a denatured hemicellulose that is obtained by reacting rice bran hemicellulose with multiple carbohydrate hydrolyzing enzymes from Shiitake mushrooms.
Objectives: The primary objective is to evaluate if 12 weeks of supplementation with arabinoxylan rice bran can safely reduce markers of inflammation during ART-suppressed HIV infection and thus potentially reduce the potential to develop end-organ disease in this group of at-risk patients.
Study population: HIV-infected participants (≥18 years of age) who have been on stable ART for at least 24 weeks prior to study entry, and have impaired immune reconstitution defined as a CD4+ T-cell count 100-350 cells/mm3 prior to study entry, with plasma HIV-1 RNA <50 copies/mL. In order to assure 24 evaluable subjects, the investigators will enroll 28 subjects total (assuming 15% lost to follow-up rate).
Study methodology: Randomized, double blind, placebo controlled clinical trial
Description of study arms: At entry participants will be randomized to one of the following arms:
Arm 1: BRM4 two 500mg capsules thrice daily p.o. for 12 weeks
Arm 2: Placebo for Biobran two capsules thrice daily p.o. for 12 weeks
Study endpoints: Primary - changes in sCD14 levels after 12 weeks of intervention. Secondary - week 12 changes in other inflammatory markers, microbial translocation, T-cell counts, and metabolic variables.
Follow-up: Participants will not be followed after study completion, unless follow-up is necessary for an adverse event.
Statistics: A total sample of 24 evaluable subjects (12 per arm) is needed to detect a clinically relevant difference of 0.07 log10 in sCD14 levels between treatment vs. placebo arms with 90% power and a 0.05 two-sided type I error rate.
Plans for analysis: For the primary analysis, changes in sCD14 (and other biomarkers) from baseline to week 12 will be compared between the treatment arm and the placebo arm by a two-sided, two-sample t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arabinoxylan Rice Bran | Experimental | Dietary Supplement: arabinoxylan rice branBRM4 two 500mg capsules thrice daily p.o. for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo for arabinoxylan rice branPlacebo for BRM4 two 500mg capsules thrice daily p.o. for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Documented HIV-1 infection
- Currently on a combination antiretroviral regimen for ≥24 weeks prior to study entry with no interruption longer than 7 consecutive days during that period.
- Plasma HIV-1 RNA levels below 50 copies/mL for at least 24 weeks prior to study entry.
- CD4+ cell count 100-350 cells/mm3 obtained within 90 days prior to study entry.
- The following laboratory values obtained within 90 days prior to entry by any US laboratory that has a CLIA certification or its equivalent.
Key exclusion criteria (8 listed)
- Change in the ART regimen within the 12 weeks prior to study entry, or anticipated/intended modification of ART during the study period.
- Two or more HIV-1 RNA determinations >200 copies/mL within the 48 week period prior to study entry.
- Use of any immunomodulator, HIV vaccine, investigational therapy, or anti-TNF therapies within 90 days prior to study entry.
- Active malignancy with expected need for systemic chemotherapy or radiation therapy during the study period.
- Pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arabinoxylan rice branAlso: Biobran, BRM4a proprietary product derived from rice bran treated with extracts from three mushrooms | Dietary supplement | Arabinoxylan Rice Bran |
| Placebo for arabinoxylan rice braninactive product | Dietary supplement | Placebo |
Primary outcome
Change from baseline in soluble CD14 levels will be compared between the supplement or placebo
Time frame: 12 weeks
Marker of macrophage activation
4 secondary outcomes
Changes in LPS levels
Time frame: 12 weeks
changes in hsCRP levels
Time frame: 12 weeks
changes in D-dimer levels
Time frame: 12 weeks
changes in soluble CD163 levels
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Dubé, MD study director
University of Souther California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arabinoxylan rice bran in people with Inflammation in HIV Infection, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in soluble CD14 levels will be compared between the supplement or placebo (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.