Ciudad Deportiva Bahía de Cádiz
Cadiz, Andalusia, Spain
NCT Number: NCT07765719
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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Notify Me16 year and older
All sexes
Interventional
Not applicable
Cadiz, Andalusia, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
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.
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.
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.
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.
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.
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.
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.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Time frame: Phase-specific baseline and end of intervention period, corresponding to Week 10.
Time frame: Phase-specific baseline and end of intervention period, corresponding to Week 10.
Time frame: Phase-specific baseline and end of intervention period, corresponding to Week 10.
Time frame: Phase-specific baseline and end of intervention period, corresponding to Week 10.
Instituto de la Grasa
Other Gov
Evaluation of New Disruptive Technologies (Steam Explosion) in the Design of Tailor-made Plant Protein Hydrolysates Applied to Sport Nutrition (PROVERDE)
Acronym: PROVERDE
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