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Effects of Cacao FLAvonoids in LOng Covid Patients (FLALOC)

Sponsor
Guillermo Ceballos Reyes (Other)
Overall Status
Recruiting
CT.gov ID
NCT06064838
Collaborator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (Other)
40
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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 strenght, fatigue scale and quality of life.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Flavonoids
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized, double-blind, placebo-controlled clinical trial will be conducted at the C.E. Indianilla in Mexico City, during the period from August 2023 to September 2024 with post-covid patients with chronic fatigue.A randomized, double-blind, placebo-controlled clinical trial will be conducted at the C.E. Indianilla in Mexico City, during the period from August 2023 to September 2024 with post-covid patients with chronic fatigue.
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Cacao FLAvonoids in LOng Covid Patients With Chronic Fatigue (FLALOC)
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Flavonoids

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

Dietary Supplement: Flavonoids
1 capsule every 12h for 90 days
Other Names:
  • Cacao&Health ECFITNESS

    		•
    Placebo Comparator: Placebo

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

    Dietary Supplement: Flavonoids
    1 capsule every 12h for 90 days
    Other Names:
  • Cacao&Health ECFITNESS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Interleukin-1b [At 0 and 90 day]

      Plasmatic concentration

    2. Interleukin-6 [At 0 and 90 day]

      Plasmatic concentration

    3. TNF-alpha [At 0 and 90 day]

      Plasmatic concentration

    4. Syndecan-1 [At 0 and 90 day]

      Plasmatic concentration

    Secondary Outcome Measures

    1. EQ-5D questionnaire [At 0 and 90 day]

      Self-administered health index that explores five domains

    2. 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.

    3. Numerical fatigue rating scale [At 0 and 90 day]

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

    4. Handgrip strength [At 0 and 90 day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 C.E. Indianilla Mexico City Mexico

    Sponsors and Collaborators

    • Guillermo Ceballos Reyes
    • Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guillermo Ceballos Reyes, Professor, National Polytechnic Institute, Mexico
    ClinicalTrials.gov Identifier:
    NCT06064838
    Other Study ID Numbers:
    • FLALOC
    First Posted:
    Oct 3, 2023
    Last Update Posted:
    Oct 3, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guillermo Ceballos Reyes, Professor, National Polytechnic Institute, Mexico
    flavonoids
    post-covid
    Additional relevant MeSH terms:
    Post-Acute COVID-19 Syndrome
    Fatigue Syndrome, Chronic
    Fatigue

    Study Results

    No Results Posted as of Oct 3, 2023