Geroprotective Precision Medicine Strategies in PWH That Use Alcohol
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in circulating senescent T cell numbers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years
- •People with HIV
- •Recent alcohol use defined as ≥42 grams in the prior week and positive urine ethyl glucuronide (EtG)
排除标准
- •Probiotic use in past 3 months
- •Recent antibiotics or immunosuppressives
- •Allergy to study products
- •Pregnancy or breastfeeding
- •Inability to comply
研究组 & 干预措施
Sequence A: Probiotic then Blueberry Extract
Participants receive probiotic for 4 weeks, washout 6 weeks, then blueberry extract for 4 weeks.
干预措施: Limosilactobacillus reuteri (Dietary Supplement)
Sequence A: Probiotic then Blueberry Extract
Participants receive probiotic for 4 weeks, washout 6 weeks, then blueberry extract for 4 weeks.
干预措施: Blueberry extract (Dietary Supplement)
Sequence B: Blueberry Extract then Probiotic
Participants receive blueberry extract for 4 weeks, washout 6 weeks, then probiotic for 4 weeks.
干预措施: Limosilactobacillus reuteri (Dietary Supplement)
Sequence B: Blueberry Extract then Probiotic
Participants receive blueberry extract for 4 weeks, washout 6 weeks, then probiotic for 4 weeks.
干预措施: Blueberry extract (Dietary Supplement)
结局指标
主要结局
Change in circulating senescent T cell numbers
时间窗: 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.
次要结局
- Change in additional senescent T cell phenotypes(Baseline and Week 4)
- Change in epigenetic age estimation(Baseline and Week 4)
研究者
David Welsh
Professor
Louisiana State University Health Sciences Center in New Orleans