Rice Bran Supplementation in Treated HIV Infection (BRM4)
|Inflammation in HIV Infection||Dietary Supplement: arabinoxylan rice bran Dietary Supplement: Placebo for arabinoxylan rice bran|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Anti-Inflammatory Effects of Arabinoxylan Rice Bran Supplementation in Participants With Treated, Suppressed HIV Infection and Inadequate Immune Reconstitution|
- 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
|Actual Study Start Date:||March 24, 2017|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02922907
|Contact: Michael P Dubé, MDemail@example.com|
|Contact: Luis Mendez, BAfirstname.lastname@example.org|
|United States, California|
|Rand Schrader Health and Research Clinic||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Michael Dube, MD 323-409-8285 email@example.com|
|Contact: Luis Mendez, BA 323.409.8283 firstname.lastname@example.org|
|Study Director:||Michael P Dubé, MD||University of Souther California|