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

September 30, 2024 updated by: Guillermo Ceballos Reyes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • C.E. Indianilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 and Health EC-Fitness
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 and Health EC-Fitness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-1b
Time Frame: At 0 and 90 day
Plasmatic concentration
At 0 and 90 day
Interleukin-6
Time Frame: At 0 and 90 day
Plasmatic concentration
At 0 and 90 day
TNF-alpha
Time Frame: At 0 and 90 day
Plasmatic concentration
At 0 and 90 day
Syndecan-1
Time Frame: At 0 and 90 day
Plasmatic concentration
At 0 and 90 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D questionnaire
Time Frame: At 0 and 90 day
Self-administered health index that explores five domains
At 0 and 90 day
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.
At 0 and 90 day
Numerical fatigue rating scale
Time Frame: At 0 and 90 day
fatigue rating scale graded 0 (best) to 100 (worst)
At 0 and 90 day
Handgrip strength
Time Frame: At 0 and 90 day
Measures static force in kilograms that the hand can squeeze around a dynamometer
At 0 and 90 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guillermo Ceballos Reyes

Collaborators

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLALOC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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