Long Covid19FLALOCNCT06064838
Effects of Cacao Flavonoids in Long COVID-19 Patients (FLALOC)
A study testing Flavonoids in people with Long Covid19 and Fatigue Syndrome, Chronic, run by Guillermo Ceballos Reyes at 1 site in Mexico.
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 strength, fatigue scale and quality of life. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Long Covid19, Fatigue Syndrome, Chronic
- What is being tested?
- Flavonoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-COVID-19 patients, at least 6 months after symptom onset
- Chronic fatigue
Who cannot join
- Allergy or intolerance caused by active ingredients
- Pregnancy or lactation
- BMI >35
- chronic liver disease
- chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cacao Flavonoids in Long COVID-19 Patients with Chronic Fatigue (FLALOC)
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.
Read the 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.
- Conditions
- Long Covid19, Fatigue Syndrome, Chronic
- Being tested
- Flavonoids
- Keywords
- flavonoids, post-covid
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavonoidsDietary supplement
Also called Cacao and Health EC-Fitness
1 capsule every 12h for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Flavonoids | Experimental | Capsules with 500mg of cacao flavonoids, twice a day for 90 days Receives: Dietary Supplement: Flavonoids |
| Placebo | Placebo comparator | Capsules with 500mg of excipients, twice a day for 90 days Receives: Dietary Supplement: Flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-1b
Plasmatic concentration
Measured: At 0 and 90 day
Interleukin-6
Plasmatic concentration
Measured: At 0 and 90 day
TNF-alpha
Plasmatic concentration
Measured: At 0 and 90 day
Syndecan-1
Plasmatic concentration
Measured: At 0 and 90 day
Secondary outcomes (4)
EQ-5D questionnaire
Self-administered health index that explores five domains
Measured: 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.
Measured: At 0 and 90 day
Numerical fatigue rating scale
fatigue rating scale graded 0 (best) to 100 (worst)
Measured: At 0 and 90 day
Handgrip strength
Measures static force in kilograms that the hand can squeeze around a dynamometer
Measured: At 0 and 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guillermo Ceballos Reyes
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Responsible party
- Sponsor-investigator, Guillermo Ceballos Reyes, National Polytechnic Institute, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064838
- Sponsor's protocol ID
- FLALOC
- Acronym
- FLALOC
- Status last verified
- Sep 2024
- First submitted
- 2 Oct 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cacao Flavonoids in Long COVID-19 Patients with Chronic Fatigue (FLALOC)
- ClinicalTrials.gov ID
- NCT06064838
- Acronym / sponsor ID
- FLALOC / FLALOC
- Conditions
- Long Covid19, Fatigue Syndrome, Chronic
- Keywords
- flavonoids, post-covid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Guillermo Ceballos ReyesUniversity, hospital or other
- Collaborators
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Flavonoids | Experimental | Dietary Supplement: FlavonoidsCapsules with 500mg of cacao flavonoids, twice a day for 90 days |
| Placebo | Placebo comparator | Dietary Supplement: FlavonoidsCapsules with 500mg of excipients, twice a day for 90 days |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-COVID-19 patients, at least 6 months after symptom onset
- Chronic fatigue
Key exclusion criteria (5 listed)
- Allergy or intolerance caused by active ingredients
- Pregnancy or lactation
- BMI >35
- chronic liver disease
- chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlavonoidsAlso: Cacao and Health EC-Fitness1 capsule every 12h for 90 days | Dietary supplement | Flavonoids, Placebo |
Primary outcome
Interleukin-1b
Time frame: At 0 and 90 day
Plasmatic concentration
Interleukin-6
Time frame: At 0 and 90 day
Plasmatic concentration
TNF-alpha
Time frame: At 0 and 90 day
Plasmatic concentration
Syndecan-1
Time frame: At 0 and 90 day
Plasmatic concentration
4 secondary outcomes
EQ-5D questionnaire
Time frame: At 0 and 90 day
Analog Visual Scale
Time frame: At 0 and 90 day
Numerical fatigue rating scale
Time frame: At 0 and 90 day
Handgrip strength
Time frame: At 0 and 90 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavonoids in people with Long Covid19 and Fatigue Syndrome, Chronic, run by Guillermo Ceballos Reyes at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-1b (time frame: At 0 and 90 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.