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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
51
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Andalusia
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Cadiz, Andalusia, Spania
- Ciudad Deportiva Bahía de Cádiz
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Adverse Events During Each Intervention Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
|
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
Tidsramme: 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.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Red Blood Cell Count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in Body Mass
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Justo Javier Pedroche Jiménez, PhD, Spanish National Research Council (CSIC)
- Hovedetterforsker: María Soledad MS Fernández Pachón, PhD, Universidad Pablo de Olavide
- Hovedetterforsker: José Antonio JA González Jurado, PhD, Universidad Pablo de Olavide
- Hovedetterforsker: Noelia María NM Rodríguez Martín, PhD, Spanish National Research Council (CSIC)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. februar 2022
Primær fullføring (Faktiske)
17. mai 2022
Studiet fullført (Faktiske)
17. mai 2022
Datoer for studieregistrering
Først innsendt
10. august 2026
Først innsendt som oppfylte QC-kriteriene
10. august 2026
Først lagt ut (Faktiske)
14. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PID2019-111368RB-I00 (Annen identifikator: Ministerio de Ciencia, Innovación y Universidades, Agencia Estatal de Investigación, Plan Nacional)
- IDI-20200562 (Annen identifikator: Centro para el Desarrollo Tecnológico Industrial (CDTI))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .