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CompletedNCT06064838FLALOCUpdated Oct 1, 2024

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

An interventional study of Flavonoids in Long Covid19 and Fatigue Syndrome, Chronic, sponsored by Guillermo Ceballos Reyes. Completed at 1 site in Mexico. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by Guillermo Ceballos Reyes · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Long Covid19
  • Fatigue Syndrome, Chronic

Keywords

  • flavonoids
  • post-covid
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 46 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Guillermo Ceballos Reyes as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Post-COVID-19 patients, at least 6 months after symptom onset
  • Chronic fatigue

Exclusion criteria

Exclusion Criteria:

  • Allergy or intolerance caused by active ingredients
  • Pregnancy or lactation
  • BMI >35
  • chronic liver disease
  • chronic kidney disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Flavonoids

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

    Dietary Supplement: Flavonoids

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Flavonoids

Interventions

  • Dietary supplementFlavonoids

    1 capsule every 12h for 90 days

    Also known as: Cacao and Health EC-Fitness

06

What researchers measure

Primary outcomes

  1. Interleukin-1b

    Plasmatic concentration

    Time frame: At 0 and 90 day

  2. Interleukin-6

    Plasmatic concentration

    Time frame: At 0 and 90 day

  3. TNF-alpha

    Plasmatic concentration

    Time frame: At 0 and 90 day

  4. Syndecan-1

    Plasmatic concentration

    Time frame: At 0 and 90 day

Secondary outcomes

  1. EQ-5D questionnaire

    Self-administered health index that explores five domains

    Time frame: At 0 and 90 day

  2. Analog Visual Scale

    Use of a Analog Visual Scale to measure the quality of life, graded 0 (worst) to 100 (best) for the perception of wellbeing.

    Time frame: At 0 and 90 day

  3. Numerical fatigue rating scale

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

    Time frame: At 0 and 90 day

  4. Handgrip strength

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

    Time frame: At 0 and 90 day

07

Study locations

1 site
  • C.E. Indianilla
    Mexico City, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06064838
Lead sponsor
Guillermo Ceballos Reyes
Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Responsible party
Guillermo Ceballos Reyes (Professor, National Polytechnic Institute, Mexico) — Sponsor-investigator
First posted
Oct 3, 2023
Start date
Aug 1, 2023
Primary completion
Aug 1, 2024
Completion
Sep 30, 2024
Last update
Oct 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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