Effects of Cacao Flavonoids in Long COVID-19 Patients (FLALOC)

NCT06064838 — Not applicable, Completed, 46 participants, Guillermo Ceballos Reyes

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Effects of Cacao Flavonoids in Long COVID-19 Patients with Chronic Fatigue (FLALOC)

Registry	NCT06064838, acronym FLALOC
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	46 (Actual)
Sponsor	Guillermo Ceballos Reyes (Other); collaborators: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Conditions	Long Covid19, Fatigue Syndrome, Chronic
Interventions	Flavonoids (Dietary supplement)
Dates	start 2023-08-01, primary completion 2024-08-01, completion 2024-09-30, first posted 2023-10-03, last updated 2024-10-01
Locations	1 site in Mexico

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Flavonoids	Experimental	Dietary Supplement: Flavonoids	Capsules with 500mg of cacao flavonoids, twice a day for 90 days
Placebo	Placebo comparator	Dietary Supplement: Flavonoids	Capsules with 500mg of excipients, twice a day for 90 days

Flavonoids (Dietary supplement), also known as Cacao and Health EC-Fitness: 1 capsule every 12h for 90 days

+Outcome measures

Primary outcomes

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
Syndecan-1 [At 0 and 90 day]: Plasmatic concentration

Secondary outcomes

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

+Eligibility

Sex: All, ages: 30 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
C.E. Indianilla	Mexico City, Mexico City	Mexico