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| Name | Class |
|---|---|
| Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flavonoids | Experimental | Capsules with 500mg of cacao flavonoids, twice a day for 90 days |
|
| Placebo | Placebo Comparator | Capsules with 500mg of excipients, twice a day for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavonoids | Dietary Supplement | 1 capsule every 12h for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D questionnaire | Self-administered health index that explores five domains | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.E. Indianilla | Mexico City | Mexico City | Mexico |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D005419 | Flavonoids |
| D000069956 | Chocolate |
| ID | Term |
|---|---|
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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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.
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| At 0 and 90 day |
| Numerical fatigue rating scale | fatigue rating scale graded 0 (best) to 100 (worst) | At 0 and 90 day |
| Handgrip strength | Measures static force in kilograms that the hand can squeeze around a dynamometer | At 0 and 90 day |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |