Effect of 14-day Red Beetroot Juice Intake on Physical Function, Gut Microbiota Composition, and Systemic Inflammation in Adults With Long COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Fatigue resistance
研究概览
简要总结
Red beetroot juice may have positive effects on multiple pathways involved in long COVID. The aim of this pilot study was to explore the impact of beetroot juice supplementation on physical function, gut microbiota, and systemic inflammation in adults with long-COVID
详细描述
A single-center, double-blind, placebo-controlled randomized trial to test the effects of 14 days of beetroot juice supplementation on functional and biological outcomes in adults with long-COVID.
Participants were randomized 1:1 to receive either daily oral supplementation with 200 mL beetroot juice or placebo for 14 days. The primary endpoint was the change from baseline to day 14 in the fatigue resistance test. Secondary outcomes included the distance walked on the 6-min walk test, handgrip strength, and flow-mediated dilation. Secondary endpoints also included changes from baseline in circulating inflammatory mediators, metagenomic and fecal water metabolomic profiles. Partial least squares discriminant analysis (PLS-DA) models were built to evaluate the differences in biological variables associated with the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a certification of a previous SARS-CoV-2 infection
- •a negative COVID-19 swab test at least four weeks prior to the screening visit
- •meet the criteria for long-COVID diagnosis according to the World Health Organization criteria
- •report persistent fatigue
排除标准
- •intolerance to beetroot juice or its derivatives
- •clinical conditions and/or use of medications that may interfere with trial outcomes (e.g., pregnancy or breastfeeding, diabetes, use of steroids or non-steroidal anti-inflammatory drugs, immunosuppressants, nitrates)
- •participation in other intervention trials for long-COVID
结局指标
主要结局
Fatigue resistance
时间窗: 14 days
The time (in seconds) when the pressure dropped to 50% of the maximum grip strength
次要结局
- Changes in the concentration of gut microbial species(14 days)
- Six-minute walk test(14 days)
- Flow-mediated dilation(14 days)
- Changes in the concentration of circulating inflammatory mediators(14 days)
- Fecal water metabolomics(14 days)
研究者
Francesco Landi
MD
Catholic University of the Sacred Heart