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Effect of Chickpea Protein Hydrolysate Supplementation on Muscle Damage and Inflammatory Plasma Markers During a Football Tournament: A Randomized, Placebo-Controlled Crossover Trial

Evaluation of New Disruptive Technologies (Steam Explosion) in the Design of Tailor-made Plant Protein Hydrolysates Applied to Sport Nutrition (PROVERDE)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07765719
Acronym
PROVERDE
Enrollment
51
Registered
2026-08-14
Start date
2022-02-14
Completion date
2022-05-17
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Exercise Recovery

Keywords

Chickpea protein hydrolysate, Plant protein hydrolysate, Bioactive peptides, Football players, Exercise-induced muscle damage, Oxidative stress, Inflammation, Sports nutrition, Protein supplementation

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTChickpea Protein Hydrolysate Beverage

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.

DIETARY_SUPPLEMENTMaltodextrin Placebo Beverage

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.

Sponsors

Instituto de la Grasa
Lead SponsorOTHER_GOV
Universidad Pablo de Olavide
CollaboratorOTHER
CDTI (Centro para el Desarrollo Tecnologico Industrial)
CollaboratorUNKNOWN
Ministerio de Ciencia e Innovacion, Spain
CollaboratorUNKNOWN
Instituto de Biomedicina (IBiS) de Sevilla
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Antioxidant ActivityPhase-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.
Change in Glutathione Peroxidase ActivityPhase-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.
Change in Glutathione Reductase ActivityPhase-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.
Change in Serum Creatinine ConcentrationBaseline 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 ActivityBaseline 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 ActivityPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Alanine Aminotransferase ActivityPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Gamma-Glutamyl Transferase ActivityPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Number of Participants With Adverse Events During Each Intervention PeriodDuring the first 4-week intervention period and the second 4-week intervention period, up to Week 10The 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.
Change in Circulating Interleukin-6 ConcentrationBaseline 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.Interleukin-6 concentration was measured using a commercial immunoassay.
Change in Circulating Interleukin-8 ConcentrationBaseline 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.Interleukin-8 concentration was measured using a commercial immunoassay.
Change in C-Reactive Protein ConcentrationBaseline 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.CRP concentration was measured using a commercial immunoassay.
Change in Creatine Kinase ActivityPhase-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.
Change in Lactate Dehydrogenase ActivityPhase-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.
Change in Myoglobin ConcentrationPhase-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.

Secondary

MeasureTime frameDescription
Change in Neutrophil CountPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Lymphocyte CountPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Monocyte CountPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Eosinophil CountPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Basophil CountBaseline 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 Platelet CountBaseline 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 Mean Platelet VolumeBaseline 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 Serum Urea ConcentrationBaseline 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 Blood Urea Nitrogen ConcentrationBaseline 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 Total Protein ConcentrationBaseline 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 Total Bilirubin ConcentrationBaseline 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 Fasting Glucose ConcentrationPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Fasting Insulin ConcentrationPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Total Cholesterol ConcentrationPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in High-Density Lipoprotein Cholesterol ConcentrationPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Low-Density Lipoprotein Cholesterol ConcentrationPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Triglyceride ConcentrationPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Red Blood Cell CountPhase-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.
Change in Hemoglobin ConcentrationPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in HematocritPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Mean Corpuscular VolumePhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Mean Corpuscular HemoglobinPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Red Cell Distribution WidthPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Total Leukocyte CountPhase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORJusto Javier Pedroche Jiménez, PhD

Spanish National Research Council (CSIC)

PRINCIPAL_INVESTIGATORMaría Soledad MS Fernández Pachón, PhD

Universidad Pablo de Olavide

PRINCIPAL_INVESTIGATORJosé Antonio JA González Jurado, PhD

Universidad Pablo de Olavide

PRINCIPAL_INVESTIGATORNoelia María NM Rodríguez Martín, PhD

Spanish National Research Council (CSIC)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026