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

NCT06064838 | Completed

• 1 other identifier: FLALOC
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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 strength, fatigue scale and quality of life.

Conditions

Long Covid19; Fatigue Syndrome, Chronic

Keywords

flavonoids; post-covid

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• EQ-5D questionnaire

  At 0 and 90 day

• Analog Visual Scale

  At 0 and 90 day

• Numerical fatigue rating scale

  At 0 and 90 day

• Handgrip strength

  At 0 and 90 day

Study Arms (2)

Flavonoids

EXPERIMENTAL

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

Dietary Supplement: Flavonoids

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Flavonoids

Interventions

Flavonoids DIETARY_SUPPLEMENT

1 capsule every 12h for 90 days

Also known as: Cacao and Health EC-Fitness

Flavonoids; Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-COVID-19 patients, at least 6 months after symptom onset
• Chronic fatigue

You may not qualify if:

• Allergy or intolerance caused by active ingredients
• Pregnancy or lactation
• BMI \>35
• chronic liver disease
• chronic kidney disease

Sponsors & Collaborators

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

Study Sites (1)

C.E. Indianilla

Mexico City, Mexico City, Mexico

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic

Interventions

Flavonoids; Chocolate

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A randomized, double-blind, placebo-controlled clinical trial will be conducted at the specialty clinic Indianilla in Mexico City, during the period from August 2023 to September 2024 with post-covid patients with chronic fatigue.

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 3, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

ME (1)