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Completed

NCT Number: NCT06064838

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

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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Key information

Conditions

Long Covid19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Infections Lung Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.E. Indianilla

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flavonoids

Dietary Supplement

1 capsule every 12h for 90 days

Other names: Cacao and Health EC-Fitness

Primary outcomes

  1. Interleukin-1b

    Time frame: At 0 and 90 day

    Plasmatic concentration

  2. Interleukin-6

    Time frame: At 0 and 90 day

    Plasmatic concentration

  3. TNF-alpha

    Time frame: At 0 and 90 day

    Plasmatic concentration

  4. Syndecan-1

    Time frame: At 0 and 90 day

    Plasmatic concentration

Secondary outcomes

  1. EQ-5D questionnaire

    Time frame: At 0 and 90 day

    Self-administered health index that explores five domains

  2. Analog Visual Scale

    Time frame: 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.

  3. Numerical fatigue rating scale

    Time frame: At 0 and 90 day

    fatigue rating scale graded 0 (best) to 100 (worst)

  4. Handgrip strength

    Time frame: At 0 and 90 day

    Measures static force in kilograms that the hand can squeeze around a dynamometer

Sponsors and collaborators

Lead sponsor

Guillermo Ceballos Reyes

Other

Collaborators

  • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Registry information

Official study title

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

Acronym: FLALOC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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