Fatigue Syndrome, Chronic, Long Covid19
Conditions
Keywords
flavonoids, post-covid
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTFlavonoids
1 capsule every 12h for 90 days
Sponsors
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Guillermo Ceballos Reyes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A randomized, double-blind, placebo-controlled clinical trial will be conducted at the specialty clinic Indianilla in Mexico City, during the period from August 2023 to September 2024 with post-covid patients with chronic fatigue.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Post-COVID-19 patients, at least 6 months after symptom onset * Chronic fatigue
Exclusion criteria
* Allergy or intolerance caused by active ingredients * Pregnancy or lactation * BMI \>35 * chronic liver disease * chronic kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Syndecan-1 | At 0 and 90 day | Plasmatic concentration |
| Interleukin-1b | At 0 and 90 day | Plasmatic concentration |
| Interleukin-6 | At 0 and 90 day | Plasmatic concentration |
| TNF-alpha | At 0 and 90 day | Plasmatic concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D questionnaire | At 0 and 90 day | Self-administered health index that explores five domains |
| Analog Visual Scale | At 0 and 90 day | Use of a Analog Visual Scale to measure the quality of life, graded 0 (worst) to 100 (best) for the perception of wellbeing. |
| Numerical fatigue rating scale | At 0 and 90 day | fatigue rating scale graded 0 (best) to 100 (worst) |
| Handgrip strength | At 0 and 90 day | Measures static force in kilograms that the hand can squeeze around a dynamometer |
Countries
Mexico
Outcome results
None listed