NCT07765719

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

Chickpea protein hydrolysatePlant protein hydrolysateBioactive peptidesFootball playersExercise-induced muscle damageOxidative stressInflammationSports nutritionProtein supplementation

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

EXPERIMENTAL

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.

Dietary Supplement: Chickpea Protein Hydrolysate Beverage

Maltodextrin Placebo Followed by Chickpea Protein Hydrolysate

EXPERIMENTAL

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.

Dietary Supplement: Maltodextrin Placebo Beverage

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.

Maltodextrin Placebo Followed by Chickpea Protein Hydrolysate

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.

Chickpea Protein Hydrolysate Followed by Maltodextrin Placebo

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

Ciudad Deportiva Bahía de Cádiz

Cadiz, Andalusia, Spain

Location

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: 39684340BACKGROUND
  • 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.

    PMID: 39721324BACKGROUND
  • 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.

    PMID: 37922804BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

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.

Locations