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

Guillermo Ceballos Reyes

Status: Completed

Conditions: Long Covid19; Fatigue Syndrome, Chronic

Treatments: Dietary Supplement: Flavonoids

Study type: Interventional

Funder types: Other

Identifiers

NCT06064838

FLALOC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Flavonoids

Experimental group

Description:

Capsules with 500mg of cacao flavonoids, twice a day for 90 days

Treatment:

Dietary Supplement: Flavonoids

Placebo

Placebo Comparator group

Description:

Capsules with 500mg of excipients, twice a day for 90 days

Treatment:

Dietary Supplement: Flavonoids