Double-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
a proprietary product derived from rice bran treated with extracts from three mushrooms
inactive product
Rand Schrader Health and Research Clinic
Los Angeles, California, United States
Change from baseline in soluble CD14 levels will be compared between the supplement or placebo
Marker of macrophage activation
Time frame: 12 weeks
Changes in LPS levels
measure of gut microbial translocation
Time frame: 12 weeks
changes in hsCRP levels
inflammatory biomarker
Time frame: 12 weeks
changes in D-dimer levels
coagulation biomarker
Time frame: 12 weeks
changes in soluble CD163 levels
marker of macrophage activation
Time frame: 12 weeks
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