Effects of Cacao FLAvonoids in LOng Covid Patients (FLALOC)

Fatigue Syndrome, Chronic Clinical Trial

— FLALOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06064838
• Other study ID #: FLALOC
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: National Polytechnic Institute, Mexico
• Contact: Munguia, MD, PhD
• Phone: 54471424
• Email: investigacion.issste19[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Fatigue Syndrome, Chronic

Intervention

Dietary Supplement:
• Flavonoids
1 capsule every 12h for 90 days

Locations

Country	Name	City	State
Mexico	C.E. Indianilla	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Guillermo Ceballos Reyes	Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-1b	Plasmatic concentration	At 0 and 90 day
Primary	Interleukin-6	Plasmatic concentration	At 0 and 90 day
Primary	TNF-alpha	Plasmatic concentration	At 0 and 90 day
Primary	Syndecan-1	Plasmatic concentration	At 0 and 90 day
Secondary	EQ-5D questionnaire	Self-administered health index that explores five domains	At 0 and 90 day
Secondary	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
Secondary	Numerical fatigue rating scale	fatigue rating scale graded 0 (best) to 100 (worst)	At 0 and 90 day
Secondary	Handgrip strength	Measures static force in kilograms that the hand can squeeze around a dynamometer	At 0 and 90 day