Effect of Chickpea Protein Hydrolysate Supplementation on Muscle Damage and Inflammatory Plasma Markers During a Football Tournament: A Randomized, Placebo-Controlled Crossover Trial (PROVERDE)
10 de agosto de 2026 actualizado por: Justo Javier Pedroche Jimenez, Instituto de la Grasa
Evaluation of New Disruptive Technologies (Steam Explosion) in the Design of Tailor-made Plant Protein Hydrolysates Applied to Sport Nutrition (PROVERDE)
This randomized, placebo-controlled crossover study evaluated the safety and potential beneficial effects of a beverage containing chickpea protein hydrolysate in football players.
Participants received the chickpea protein hydrolysate beverage and a matched protein-containing placebo beverage during two four-week intervention periods separated by a two-week washout period.
The study assessed biochemical safety parameters, antioxidant status, inflammatory biomarkers, lipid profile, lipid peroxidation, muscle damage markers, dietary intake, and body composition.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study was designed as a randomized, placebo-controlled crossover nutritional intervention conducted in football players during the competitive season. Participants were randomly allocated to one of two intervention sequences, with allocation balanced according to playing position.
During the first four-week intervention period, one sequence received the experimental beverage containing chickpea protein hydrolysate, whereas the other sequence received a matched placebo beverage. This was followed by a two-week washout period. During the second four-week intervention period, the treatments were crossed over so that each participant received the alternative beverage. A further two-week washout period was included after the second intervention.
On training days, the experimental beverage was consumed 2-4 hours before training at a dose providing 0.2 g protein/kg body weight and approximately 30 minutes after training at a dose providing 0.3 g protein/kg body weight. The placebo beverage followed the same administration schedule and was designed to have a similar appearance and taste and the same protein content, but from a different protein source.
Blood sampling, dietary assessment, and anthropometric measurements were scheduled at baseline and during the intervention and washout periods. The study evaluated biochemical markers related to protein and hepatic metabolism, hematological parameters, glucose and insulin, antioxidant status, inflammatory biomarkers, lipid profile, lipid peroxidation, muscle damage markers, adverse events, dietary intake, and body composition.
Tipo de estudio
Intervencionista
Inscripción (Actual)
51
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Andalusia
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Cadiz, Andalusia, España
- Ciudad Deportiva Bahía de Cádiz
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Football player belonging to one of the participating professional, semiprofessional, or amateur football teams.
- Regular participation in the team's training sessions and matches.
- Considered healthy based on medical history, biochemical assessment, body composition, lifestyle assessment, and dietary evaluation.
- Ability and willingness to comply with the study procedures and beverage consumption schedule.
- Provision of written informed consent.
Exclusion Criteria:
- Presence of chronic disease, including cardiovascular disease, diabetes, cancer, or metabolic syndrome.
- Overweight, renal impairment, or hepatic impairment.
- Abnormal biochemical test results considered clinically relevant by the research team.
- Known allergy to chickpea.
- Use of medication or nutritional supplements during the four weeks preceding enrollment.
- Current smoking.
- Participation in another similar study during the previous three months.
- Completion of less than 75% of the scheduled training sessions or matches during the study.
- Failure to consume 100% of the assigned study beverage.
- Any circumstance that, in the opinion of the research team, could impair participation or compliance with the study procedures.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Chickpea Protein Hydrolysate Followed by Maltodextrin Placebo
Participants received the chickpea protein hydrolysate beverage for four weeks, followed by a two-week washout period.
They subsequently received the maltodextrin placebo beverage for four weeks, followed by a final two-week washout period.
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A powdered beverage containing chickpea protein hydrolysate was reconstituted in water before consumption.
On training days, participants consumed a dose providing 0.2 g protein/kg body weight 2-4 hours before training and 0.3 g protein/kg body weight approximately 30 minutes after training.
The intervention was administered for four weeks during the corresponding study period.
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Experimental: Maltodextrin Placebo Followed by Chickpea Protein Hydrolysate
Participants received the maltodextrin placebo beverage for four weeks, followed by a two-week washout period.
They subsequently received the chickpea protein hydrolysate beverage for four weeks, followed by a final two-week washout period.
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A maltodextrin-containing placebo beverage designed to resemble the chickpea protein hydrolysate beverage in appearance and taste.
The placebo was administered according to the same timing schedule as the experimental beverage for four weeks during the corresponding study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Adverse Events During Each Intervention Period
Periodo de tiempo: During the first 4-week intervention period and the second 4-week intervention period, up to Week 10
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The number of participants reporting one or more adverse events during consumption of the chickpea protein hydrolysate beverage or the maltodextrin placebo beverage was recorded.
Adverse events included any unfavorable symptom or clinical event reported by a participant or identified by the research team during the intervention periods.
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During the first 4-week intervention period and the second 4-week intervention period, up to Week 10
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Change in Circulating Interleukin-6 Concentration
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Interleukin-6 concentration was measured using a commercial immunoassay.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Circulating Interleukin-8 Concentration
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Interleukin-8 concentration was measured using a commercial immunoassay.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in C-Reactive Protein Concentration
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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CRP concentration was measured using a commercial immunoassay.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Creatine Kinase Activity
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Kinase activity was measured in fasting blood samples.
For the crossover comparison, the change during each intervention phase was calculated as the value at the end of the 4-week phase minus the corresponding phase-specific baseline value.
Changes during the chickpea protein hydrolysate and maltodextrin placebo phases were compared within participants.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Lactate Dehydrogenase Activity
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Lactate Dehydrogenase Activity was measured in fasting blood samples.
For the crossover comparison, the change during each intervention phase was calculated as the value at the end of the 4-week phase minus the corresponding phase-specific baseline value.
Changes during the chickpea protein hydrolysate and maltodextrin placebo phases were compared within participants.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Myoglobin Concentration
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Myoglobin Concentration was measured in fasting blood samples.
For the crossover comparison, the change during each intervention phase was calculated as the value at the end of the 4-week phase minus the corresponding phase-specific baseline value.
Changes during the chickpea protein hydrolysate and maltodextrin placebo phases were compared within participants.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Antioxidant Activity
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Ferric Reducing Antioxidant Power, Trolox Equivalent Antioxidant Capacity, and Oxygen Radical Absorbance Capacity was measured in fasting blood samples.
For the crossover comparison, the change during each intervention phase was calculated as the value at the end of the 4-week phase minus the corresponding phase-specific baseline value.
Changes during the chickpea protein hydrolysate and maltodextrin placebo phases were compared within participants.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Glutathione Peroxidase Activity
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Glutathione Peroxidase Activity was measured in fasting blood samples.
For the crossover comparison, the change during each intervention phase was calculated as the value at the end of the 4-week phase minus the corresponding phase-specific baseline value.
Changes during the chickpea protein hydrolysate and maltodextrin placebo phases were compared within participants.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Glutathione Reductase Activity
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Glutathione Reductase Activity was measured in fasting blood samples.
For the crossover comparison, the change during each intervention phase was calculated as the value at the end of the 4-week phase minus the corresponding phase-specific baseline value.
Changes during the chickpea protein hydrolysate and maltodextrin placebo phases were compared within participants.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Serum Creatinine Concentration
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Alkaline Phosphatase Activity
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Aspartate Aminotransferase Activity
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Alanine Aminotransferase Activity
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Gamma-Glutamyl Transferase Activity
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Red Blood Cell Count
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Red Blood Cell Count was measured in fasting blood samples as part of the predefined biochemical and hematological safety assessment.
For the crossover comparison, the change during each intervention phase was calculated as the end-of-phase value minus the corresponding phase-specific baseline value.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Hemoglobin Concentration
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Hematocrit
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Mean Corpuscular Volume
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Mean Corpuscular Hemoglobin
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Red Cell Distribution Width
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Total Leukocyte Count
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Neutrophil Count
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Lymphocyte Count
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Monocyte Count
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Eosinophil Count
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Basophil Count
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Platelet Count
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Mean Platelet Volume
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Serum Urea Concentration
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Blood Urea Nitrogen Concentration
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Total Protein Concentration
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Total Bilirubin Concentration
Periodo de tiempo: Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Baseline and Weeks 4, 6, 10, and 12; the primary crossover comparison used the phase-specific changes from Weeks 0 to 4 and Weeks 6 to 10.
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Change in Fasting Glucose Concentration
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Fasting Insulin Concentration
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Total Cholesterol Concentration
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in High-Density Lipoprotein Cholesterol Concentration
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Low-Density Lipoprotein Cholesterol Concentration
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Triglyceride Concentration
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in Body Mass
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Body Mass Index
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Body Fat Percentage
Periodo de tiempo: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Change in Daily Energy Intake
Periodo de tiempo: Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Change in Daily Carbohydrate Intake
Periodo de tiempo: Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Change in Daily Protein Intake
Periodo de tiempo: Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Change in Daily Fat Intake
Periodo de tiempo: Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Justo Javier Pedroche Jiménez, PhD, Spanish National Research Council (CSIC)
- Investigador principal: María Soledad MS Fernández Pachón, PhD, Universidad Pablo de Olavide
- Investigador principal: José Antonio JA González Jurado, PhD, Universidad Pablo de Olavide
- Investigador principal: Noelia María NM Rodríguez Martín, PhD, Spanish National Research Council (CSIC)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Alcala-Santiago A, Toscano-Sanchez R, Marquez-Lopez JC, Gonzalez-Jurado JA, Fernandez-Pachon MS, Garcia-Villanova B, Pedroche J, Rodriguez-Martin NM. The Synergic Immunomodulatory Effect of Vitamin D and Chickpea Protein Hydrolysate in THP-1 Cells: An In Vitro Approach. Int J Mol Sci. 2024 Nov 25;25(23):12628. doi: 10.3390/ijms252312628.
- Rodriguez-Martin NM, Marquez-Lopez JC, Gonzalez-Jurado JA, Millan F, Pedroche J, Fernandez-Pachon MS. The immunomodulatory potential of chickpea protein hydrolysate via ROS and NO pathways. Biomed Pharmacother. 2025 Jan;182:117794. doi: 10.1016/j.biopha.2024.117794. Epub 2024 Dec 24.
- Rodriguez-Martin NM, Marquez-Lopez JC, Cerrillo I, Millan F, Gonzalez-Jurado JA, Fernandez-Pachon MS, Pedroche J. Production of chickpea protein hydrolysate at laboratory and pilot plant scales: Optimization using principal component analysis based on antioxidant activities. Food Chem. 2024 Mar 30;437(Pt 1):137707. doi: 10.1016/j.foodchem.2023.137707. Epub 2023 Oct 18.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de febrero de 2022
Finalización primaria (Actual)
17 de mayo de 2022
Finalización del estudio (Actual)
17 de mayo de 2022
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de agosto de 2026
Publicado por primera vez (Actual)
14 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PID2019-111368RB-I00 (Otro identificador: Ministerio de Ciencia, Innovación y Universidades, Agencia Estatal de Investigación, Plan Nacional)
- IDI-20200562 (Otro identificador: Centro para el Desarrollo Tecnológico Industrial (CDTI))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared because external sharing of participant-level data was not included in the original informed consent and no prospective IPD sharing plan was established.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .