Rice Bran Supplementation in Treated HIV Infection (BRM4)
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|ClinicalTrials.gov Identifier: NCT02922907|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : December 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inflammation in HIV Infection||Dietary Supplement: arabinoxylan rice bran Dietary Supplement: Placebo for arabinoxylan rice bran||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Anti-Inflammatory Effects of Arabinoxylan Rice Bran Supplementation in Participants With Treated, Suppressed HIV Infection and Inadequate Immune Reconstitution|
|Actual Study Start Date :||March 24, 2017|
|Actual Primary Completion Date :||December 7, 2018|
|Estimated Study Completion Date :||August 2019|
Experimental: Arabinoxylan Rice Bran
BRM4 two 500mg capsules thrice daily p.o. for 12 weeks
Dietary Supplement: arabinoxylan rice bran
a proprietary product derived from rice bran treated with extracts from three mushrooms
Other Name: Biobran, BRM4
Placebo Comparator: Placebo
Placebo for BRM4 two 500mg capsules thrice daily p.o. for 12 weeks
Dietary Supplement: Placebo for arabinoxylan rice bran
- Change from baseline in soluble CD14 levels will be compared between the supplement or placebo [ Time Frame: 12 weeks ]Marker of macrophage activation
- Changes in LPS levels [ Time Frame: 12 weeks ]measure of gut microbial translocation
- changes in hsCRP levels [ Time Frame: 12 weeks ]inflammatory biomarker
- changes in D-dimer levels [ Time Frame: 12 weeks ]coagulation biomarker
- changes in soluble CD163 levels [ Time Frame: 12 weeks ]marker of macrophage activation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922907
|United States, California|
|Rand Schrader Health and Research Clinic|
|Los Angeles, California, United States, 90033|
|Study Director:||Michael P Dubé, MD||University of Souther California|