Effects of Cacao FLAvonoids in LOng Covid Patients (FLALOC)

Study Overview
=================
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.

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.

Official Title
-----------------
Effects of Cacao FLAvonoids in LOng Covid Patients With Chronic Fatigue (FLALOC)

Conditions
-----------------
Long Covid19, Fatigue Syndrome, Chronic

Intervention / Treatment
-----------------
* Dietary Supplement: Flavonoids


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flavonoids<br>Capsules with 500mg of cacao flavonoids, twice a day for 90 days | Dietary Supplement: Flavonoids<br>* 1 capsule every 12h for 90 days<br>* Other names: Cacao&Health ECFITNESS;|
| Placebo Comparator: Placebo<br>Capsules with 500mg of excipients, twice a day for 90 days | Dietary Supplement: Flavonoids<br>* 1 capsule every 12h for 90 days<br>* Other names: Cacao&Health ECFITNESS;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flavonoids, post-covid