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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06064838




Registration number
NCT06064838
Ethics application status
Date submitted
2/10/2023
Date registered
3/10/2023
Date last updated
1/10/2024

Titles & IDs
Public title
Effects of Cacao Flavonoids in Long COVID-19 Patients (FLALOC)
Scientific title
Effects of Cacao Flavonoids in Long COVID-19 Patients with Chronic Fatigue (FLALOC)
Secondary ID [1] 0 0
FLALOC
Universal Trial Number (UTN)
Trial acronym
FLALOC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long Covid19 0 0
Fatigue Syndrome, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Other 0 0 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Flavonoids

Experimental: Flavonoids - Capsules with 500mg of cacao flavonoids, twice a day for 90 days

Placebo comparator: Placebo - Capsules with 500mg of excipients, twice a day for 90 days


Treatment: Other: Flavonoids
1 capsule every 12h for 90 days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Interleukin-1b
Timepoint [1] 0 0
At 0 and 90 day
Primary outcome [2] 0 0
Interleukin-6
Timepoint [2] 0 0
At 0 and 90 day
Primary outcome [3] 0 0
TNF-alpha
Timepoint [3] 0 0
At 0 and 90 day
Primary outcome [4] 0 0
Syndecan-1
Timepoint [4] 0 0
At 0 and 90 day
Secondary outcome [1] 0 0
EQ-5D questionnaire
Timepoint [1] 0 0
At 0 and 90 day
Secondary outcome [2] 0 0
Analog Visual Scale
Timepoint [2] 0 0
At 0 and 90 day
Secondary outcome [3] 0 0
Numerical fatigue rating scale
Timepoint [3] 0 0
At 0 and 90 day
Secondary outcome [4] 0 0
Handgrip strength
Timepoint [4] 0 0
At 0 and 90 day

Eligibility
Key inclusion criteria
* Post-COVID-19 patients, at least 6 months after symptom onset
* Chronic fatigue
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Allergy or intolerance caused by active ingredients
* Pregnancy or lactation
* BMI >35
* chronic liver disease
* chronic kidney disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2024
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Mexico
State/province [1] 0 0
Mexico City

Funding & Sponsors
Primary sponsor type
Other
Name
Guillermo Ceballos Reyes
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06064838
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06064838