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

NCT ID: NCT06064838

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Long Covid19 Fatigue Syndrome, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Flavonoids

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

Group Type EXPERIMENTAL

Flavonoids

Intervention Type DIETARY_SUPPLEMENT

1 capsule every 12h for 90 days

Placebo

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

Group Type PLACEBO_COMPARATOR

Flavonoids

Intervention Type DIETARY_SUPPLEMENT

1 capsule every 12h for 90 days

Interventions

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Flavonoids

1 capsule every 12h for 90 days

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cacao and Health EC-Fitness

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

OTHER_GOV

Sponsor Role collaborator

Guillermo Ceballos Reyes

OTHER

Sponsor Role lead

Responsible Party

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Guillermo Ceballos Reyes

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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C.E. Indianilla

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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FLALOC

Identifier Type: -

Identifier Source: org_study_id

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