Effect of Chickpea Protein Hydrolysate Supplementation on Muscle Damage and Inflammatory Plasma Markers During a Football Tournament: A Randomized, Placebo-Controlled Crossover Trial
PROVERDE
Evaluation of New Disruptive Technologies (Steam Explosion) in the Design of Tailor-made Plant Protein Hydrolysates Applied to Sport Nutrition (PROVERDE)
2 other identifiers
interventional
51
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2022
CompletedFirst Submitted
Initial submission to the registry
August 10, 2026
CompletedFirst Posted
Study publicly available on registry
August 14, 2026
CompletedAugust 14, 2026
August 1, 2026
3 months
August 10, 2026
August 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Number of Participants With Adverse Events During Each Intervention Period
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.
During the first 4-week intervention period and the second 4-week intervention period, up to Week 10
Change in Circulating Interleukin-6 Concentration
Interleukin-6 concentration was measured using a commercial immunoassay.
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.
Change in Circulating Interleukin-8 Concentration
Interleukin-8 concentration was measured using a commercial immunoassay.
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.
Change in C-Reactive Protein Concentration
CRP concentration was measured using a commercial immunoassay.
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.
Change in Creatine Kinase Activity
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.
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Lactate Dehydrogenase Activity
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.
Change in Myoglobin Concentration
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.
Change in Antioxidant Activity
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.
Change in Glutathione Peroxidase Activity
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.
Change in Glutathione Reductase Activity
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.
Change in Serum Creatinine Concentration
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.
Change in Alkaline Phosphatase Activity
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.
Change in Aspartate Aminotransferase Activity
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Alanine Aminotransferase Activity
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Gamma-Glutamyl Transferase Activity
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Secondary Outcomes (24)
Change in Red Blood Cell Count
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Hemoglobin Concentration
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Hematocrit
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Mean Corpuscular Volume
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Mean Corpuscular Hemoglobin
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
- +19 more secondary outcomes
Other Outcomes (7)
Change in Body Mass
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Body Mass Index
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Body Fat Percentage
Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
- +4 more other outcomes
Study Arms (2)
Chickpea Protein Hydrolysate Followed by Maltodextrin Placebo
EXPERIMENTALParticipants 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.
Maltodextrin Placebo Followed by Chickpea Protein Hydrolysate
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Instituto de la Grasalead
- Universidad Pablo de Olavidecollaborator
- CDTI (Centro para el Desarrollo Tecnologico Industrial)collaborator
- Instituto de Biomedicina (IBiS) de Sevillacollaborator
- Ministerio de Ciencia e Innovacion, Spaincollaborator
Study Sites (1)
Ciudad Deportiva Bahía de Cádiz
Cadiz, Andalusia, Spain
Related Publications (3)
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.
PMID: 39684340BACKGROUNDRodriguez-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.
PMID: 39721324BACKGROUNDRodriguez-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.
PMID: 37922804BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justo Javier Pedroche Jiménez, PhD
Spanish National Research Council (CSIC)
- PRINCIPAL INVESTIGATOR
María Soledad MS Fernández Pachón, PhD
Universidad Pablo de Olavide
- PRINCIPAL INVESTIGATOR
José Antonio JA González Jurado, PhD
Universidad Pablo de Olavide
- PRINCIPAL INVESTIGATOR
Noelia María NM Rodríguez Martín, PhD
Spanish National Research Council (CSIC)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tenured scientist
Study Record Dates
First Submitted
August 10, 2026
First Posted
August 14, 2026
Study Start
February 14, 2022
Primary Completion
May 17, 2022
Study Completion
May 17, 2022
Last Updated
August 14, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
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.