Aging, Alcohol Drinking, HIV Infections, Immunosenescence
Conditions
Keywords
People with HIV, Alcohol use, Immunosenescence, Senescence, Microbiome, Probiotic, Blueberry extract, Crossover trial
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLimosilactobacillus reuteri
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.
DIETARY_SUPPLEMENTBlueberry extract
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.
Sponsors
Louisiana State University Health Sciences Center in New Orleans
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double (Participant, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥40 years * People with HIV * Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)
Exclusion criteria
* Probiotic use in past 3 months * Recent antibiotics or immunosuppressives * Allergy to study products * Pregnancy or breastfeeding * Inability to comply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in circulating senescent T cell numbers | Time 0 to Week 4 of treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in additional senescent T cell phenotypes | Baseline and Week 4 | Flow cytometry-defined subsets |
| Change in epigenetic age estimation | Baseline and Week 4 | Change in DNA methylation-based age estimates using epigenetic clock analyses. |
Countries
United States
Contacts
CONTACTDavid A Welsh, MD
PRINCIPAL_INVESTIGATORDavid A Welsh, MD
LSU Health New Orleans
Outcome results
None listed