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. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
51
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Andalusia
-
Cadiz, Andalusia, Spanien
- Ciudad Deportiva Bahía de Cádiz
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
|
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants With Adverse Events During Each Intervention Period
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Red Blood Cell Count
Zeitfenster: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
|
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Change in Body Mass
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Justo Javier Pedroche Jiménez, PhD, Spanish National Research Council (CSIC)
- Hauptermittler: María Soledad MS Fernández Pachón, PhD, Universidad Pablo de Olavide
- Hauptermittler: José Antonio JA González Jurado, PhD, Universidad Pablo de Olavide
- Hauptermittler: Noelia María NM Rodríguez Martín, PhD, Spanish National Research Council (CSIC)
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
14. Februar 2022
Primärer Abschluss (Tatsächlich)
17. Mai 2022
Studienabschluss (Tatsächlich)
17. Mai 2022
Studienanmeldedaten
Zuerst eingereicht
10. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. August 2026
Zuerst gepostet (Tatsächlich)
14. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PID2019-111368RB-I00 (Andere Kennung: Ministerio de Ciencia, Innovación y Universidades, Agencia Estatal de Investigación, Plan Nacional)
- IDI-20200562 (Andere Kennung: Centro para el Desarrollo Tecnológico Industrial (CDTI))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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