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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
51
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Andalusia
-
Cadiz, Andalusia, Spanien
- Ciudad Deportiva Bahía de Cádiz
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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.
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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 |
Foranstaltningsbeskrivelse |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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 |
|---|---|
|
Change in Body Mass
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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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.
|
Phase-specific baseline and end of intervention period, corresponding to Week 10.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Justo Javier Pedroche Jiménez, PhD, Spanish National Research Council (CSIC)
- Ledende efterforsker: María Soledad MS Fernández Pachón, PhD, Universidad Pablo de Olavide
- Ledende efterforsker: José Antonio JA González Jurado, PhD, Universidad Pablo de Olavide
- Ledende efterforsker: Noelia María NM Rodríguez Martín, PhD, Spanish National Research Council (CSIC)
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. februar 2022
Primær færdiggørelse (Faktiske)
17. maj 2022
Studieafslutning (Faktiske)
17. maj 2022
Datoer for studieregistrering
Først indsendt
10. august 2026
Først indsendt, der opfyldte QC-kriterier
10. august 2026
Først opslået (Faktiske)
14. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PID2019-111368RB-I00 (Anden identifikator: Ministerio de Ciencia, Innovación y Universidades, Agencia Estatal de Investigación, Plan Nacional)
- IDI-20200562 (Anden identifikator: Centro para el Desarrollo Tecnológico Industrial (CDTI))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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