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Completed

NCT Number: NCT07765719

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ciudad Deportiva Bahía de Cádiz

Cadiz, Andalusia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chickpea Protein Hydrolysate Beverage

Dietary Supplement

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.

Maltodextrin Placebo Beverage

Dietary Supplement

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.

Primary outcomes

  1. Number of Participants With Adverse Events During Each Intervention Period

    Time frame: During the first 4-week intervention period and the second 4-week intervention period, up to Week 10

    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.

  2. Change in Circulating Interleukin-6 Concentration

    Time frame: 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.

    Interleukin-6 concentration was measured using a commercial immunoassay.

  3. Change in Circulating Interleukin-8 Concentration

    Time frame: 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.

    Interleukin-8 concentration was measured using a commercial immunoassay.

  4. Change in C-Reactive Protein Concentration

    Time frame: 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.

    CRP concentration was measured using a commercial immunoassay.

  5. Change in Creatine Kinase Activity

    Time frame: 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.

  6. Change in Lactate Dehydrogenase Activity

    Time frame: 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.

  7. Change in Myoglobin Concentration

    Time frame: 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.

  8. Change in Antioxidant Activity

    Time frame: 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.

  9. Change in Glutathione Peroxidase Activity

    Time frame: 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.

  10. Change in Glutathione Reductase Activity

    Time frame: 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.

  11. Change in Serum Creatinine Concentration

    Time frame: 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.

  12. Change in Alkaline Phosphatase Activity

    Time frame: 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.

  13. Change in Aspartate Aminotransferase Activity

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  14. Change in Alanine Aminotransferase Activity

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  15. Change in Gamma-Glutamyl Transferase Activity

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

Secondary outcomes

  1. Change in Red Blood Cell Count

    Time frame: 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.

  2. Change in Hemoglobin Concentration

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  3. Change in Hematocrit

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  4. Change in Mean Corpuscular Volume

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  5. Change in Mean Corpuscular Hemoglobin

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  6. Change in Red Cell Distribution Width

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  7. Change in Total Leukocyte Count

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  8. Change in Neutrophil Count

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  9. Change in Lymphocyte Count

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  10. Change in Monocyte Count

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  11. Change in Eosinophil Count

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  12. Change in Basophil Count

    Time frame: 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.

  13. Change in Platelet Count

    Time frame: 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.

  14. Change in Mean Platelet Volume

    Time frame: 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.

  15. Change in Serum Urea Concentration

    Time frame: 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.

  16. Change in Blood Urea Nitrogen Concentration

    Time frame: 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.

  17. Change in Total Protein Concentration

    Time frame: 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.

  18. Change in Total Bilirubin Concentration

    Time frame: 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.

  19. Change in Fasting Glucose Concentration

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  20. Change in Fasting Insulin Concentration

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  21. Change in Total Cholesterol Concentration

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  22. Change in High-Density Lipoprotein Cholesterol Concentration

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  23. Change in Low-Density Lipoprotein Cholesterol Concentration

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  24. Change in Triglyceride Concentration

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

Other outcomes

  1. Change in Body Mass

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  2. Change in Body Mass Index

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  3. Change in Body Fat Percentage

    Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.

  4. Change in Daily Energy Intake

    Time frame: Phase-specific baseline and end of intervention period, corresponding to Week 10.

  5. Change in Daily Carbohydrate Intake

    Time frame: Phase-specific baseline and end of intervention period, corresponding to Week 10.

  6. Change in Daily Protein Intake

    Time frame: Phase-specific baseline and end of intervention period, corresponding to Week 10.

  7. Change in Daily Fat Intake

    Time frame: Phase-specific baseline and end of intervention period, corresponding to Week 10.

Sponsors and collaborators

Lead sponsor

Instituto de la Grasa

Other Gov

Collaborators

  • CDTI (Centro para el Desarrollo Tecnologico Industrial)
  • Instituto de Biomedicina (IBiS) de Sevilla
  • Ministerio de Ciencia e Innovacion, Spain
  • Universidad Pablo de Olavide

Registry information

Official study title

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

Acronym: PROVERDE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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