Effects of Cacao Flavonoids in Long COVID-19 Patients with Chronic Fatigue (FLALOC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Syndecan-1
研究概览
简要总结
The study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo to evaluate the effect of daily consumption of a cacao supplement on inflammation, endothelial damage, handgrip strength, fatigue scale and quality of life.
详细描述
The study use a triple blind, placebo-controlled design enrolling male and female subjects between 30-70 yo distributed homogeneously at random in two groups: the control group (Placebo) and the intervention group (Cacao Flavonoids) both groups affected for 90 days.
The variables to consider will be: Interleukins (IL-1b, IL-6), Tumoral Necrosis Factor alpha (TNF-α) and syndecan-1.
For physical performance is evaluated the handgrip strength. The investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire, and the numerical fatigue rating scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-COVID-19 patients, at least 6 months after symptom onset
- •Chronic fatigue
排除标准
- •Allergy or intolerance caused by active ingredients
- •Pregnancy or lactation
- •chronic liver disease
- •chronic kidney disease
结局指标
主要结局
Syndecan-1
时间窗: At 0 and 90 day
Plasmatic concentration
Interleukin-1b
时间窗: At 0 and 90 day
Plasmatic concentration
TNF-alpha
时间窗: At 0 and 90 day
Plasmatic concentration
Interleukin-6
时间窗: At 0 and 90 day
Plasmatic concentration
次要结局
- EQ-5D questionnaire(At 0 and 90 day)
- Analog Visual Scale(At 0 and 90 day)
- Handgrip strength(At 0 and 90 day)
- Numerical fatigue rating scale(At 0 and 90 day)
研究者
Guillermo Ceballos Reyes
Professor
National Polytechnic Institute, Mexico