People with HIV who drink alcohol are at increased risk for accelerated aging biology, including increased immune senescence. This randomized, double-blind, crossover clinical trial evaluates two generally recognized as safe (GRAS) microbiota-targeted interventions on immune senescence biomarkers.
This is a randomized, double-blind, controlled, crossover mechanistic clinical trial in people with HIV who have recent alcohol use. Participants are randomized to receive either Limosilactobacillus reuteri probiotic or blueberry extract first for 4 weeks, followed by a 6-week washout period, then crossover to the alternate intervention for 4 weeks. Each participant receives both interventions. Both interventions are generally recognized as safe (GRAS) dietary supplements and are not intended to diagnose, treat, cure, or prevent disease. This study is not conducted under an Investigational New Drug (IND) application and does not involve FDA-regulated investigational products. Biospecimen collection and clinical assessments are performed at baseline and Week 4 of each intervention period. The primary analysis compares within-participant changes in immune senescence markers between interventions using a crossover design framework and accounts for period and sequence effects. Participants will be recruited from HIV clinical care programs, affiliated clinics, and community outreach efforts in the New Orleans area. A 6-week washout period is included to minimize potential carryover effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
160
Administered as 6 capsules daily (3 twice daily) for 4 weeks. Each daily dose contains 1×10\^10 CFU total in a 1:1 ratio of two strains. This is a GRAS dietary supplement and not an FDA-regulated investigational product.
Administered as 6 capsules daily (3 twice daily) for 4 weeks, providing 500 mg anthocyanins per day. This is a GRAS dietary supplement and not an FDA-regulated investigational product.
LSU Health
New Orleans, Louisiana, United States
Change in circulating senescent T cell numbers
Change in circulating CD3+CD8+CD28-CD38+ T cell count (cells/µL) during treatment period. Measured by multiparameter flow cytometry. The primary endpoint is the within-participant difference in change from baseline.
Time frame: Time 0 to Week 4 of treatment period
Change in additional senescent T cell phenotypes
Flow cytometry-defined subsets
Time frame: Baseline and Week 4
Change in epigenetic age estimation
Change in DNA methylation-based age estimates using epigenetic clock analyses.
Time frame: Baseline and Week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.