Effects of Cacao FLAvonoids in LOng Covid Patients (FLALOC) (FLALOC)
Primary Purpose
Long Covid19, Fatigue Syndrome, Chronic
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Flavonoids
Sponsored by
About this trial
This is an interventional treatment trial for Long Covid19 focused on measuring flavonoids, post-covid
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
Sites / Locations
- C.E. IndianillaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Flavonoids
Placebo
Arm Description
Capsules with 500mg of cacao flavonoids, twice a day for 90 days
Capsules with 500mg of excipients, twice a day for 90 days
Outcomes
Primary Outcome Measures
Interleukin-1b
Plasmatic concentration
Interleukin-6
Plasmatic concentration
TNF-alpha
Plasmatic concentration
Syndecan-1
Plasmatic concentration
Secondary Outcome Measures
EQ-5D questionnaire
Self-administered health index that explores five domains
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.
Numerical fatigue rating scale
fatigue rating scale graded 0 (best) to 100 (worst)
Handgrip strength
Measures static force in kilograms that the hand can squeeze around a dynamometer
Full Information
NCT ID
NCT06064838
First Posted
October 2, 2023
Last Updated
October 2, 2023
Sponsor
Guillermo Ceballos Reyes
Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
1. Study Identification
Unique Protocol Identification Number
NCT06064838
Brief Title
Effects of Cacao FLAvonoids in LOng Covid Patients (FLALOC)
Acronym
FLALOC
Official Title
Effects of Cacao FLAvonoids in LOng Covid Patients With Chronic Fatigue (FLALOC)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guillermo Ceballos Reyes
Collaborators
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Covid19, Fatigue Syndrome, Chronic
Keywords
flavonoids, post-covid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flavonoids
Arm Type
Experimental
Arm Description
Capsules with 500mg of cacao flavonoids, twice a day for 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules with 500mg of excipients, twice a day for 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Flavonoids
Other Intervention Name(s)
Cacao&Health ECFITNESS
Intervention Description
1 capsule every 12h for 90 days
Primary Outcome Measure Information:
Title
Interleukin-1b
Description
Plasmatic concentration
Time Frame
At 0 and 90 day
Title
Interleukin-6
Description
Plasmatic concentration
Time Frame
At 0 and 90 day
Title
TNF-alpha
Description
Plasmatic concentration
Time Frame
At 0 and 90 day
Title
Syndecan-1
Description
Plasmatic concentration
Time Frame
At 0 and 90 day
Secondary Outcome Measure Information:
Title
EQ-5D questionnaire
Description
Self-administered health index that explores five domains
Time Frame
At 0 and 90 day
Title
Analog Visual Scale
Description
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
Title
Numerical fatigue rating scale
Description
fatigue rating scale graded 0 (best) to 100 (worst)
Time Frame
At 0 and 90 day
Title
Handgrip strength
Description
Measures static force in kilograms that the hand can squeeze around a dynamometer
Time Frame
At 0 and 90 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Munguia, MD, PhD
Phone
54471424
Email
investigacion.issste19@gmail.com
Facility Information:
Facility Name
C.E. Indianilla
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Email
investigacion.issste19@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Cacao FLAvonoids in LOng Covid Patients (FLALOC)
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