Evaluation of New Disruptive Technologies (Steam Explosion) in the Design of Tailor-made Plant Protein Hydrolysates Applied to Sport Nutrition (PROVERDE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Aspartate Aminotransferase Activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Chickpea Protein Hydrolysate Followed by Maltodextrin Placebo
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.
干预措施: Chickpea Protein Hydrolysate Beverage (Dietary Supplement)
Maltodextrin Placebo Followed by Chickpea Protein Hydrolysate
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.
干预措施: Maltodextrin Placebo Beverage (Dietary Supplement)
结局指标
主要结局
Change in Aspartate Aminotransferase Activity
时间窗: Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.
Change in Alanine Aminotransferase Activity
时间窗: 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
时间窗: Phase-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 Period
时间窗: 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.
Change in Circulating Interleukin-6 Concentration
时间窗: 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.
Change in Circulating Interleukin-8 Concentration
时间窗: 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.
Change in C-Reactive Protein Concentration
时间窗: 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.
Change in Creatine Kinase Activity
时间窗: 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.
Change in Lactate Dehydrogenase Activity
时间窗: 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.
Change in Myoglobin Concentration
时间窗: 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.
Change in Antioxidant Activity
时间窗: 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.
Change in Glutathione Peroxidase Activity
时间窗: 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.
Change in Glutathione Reductase Activity
时间窗: 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.
Change in Serum Creatinine Concentration
时间窗: 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
时间窗: 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.
次要结局
- Change in Total Leukocyte Count(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Neutrophil Count(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- 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.)
- Change in Red Cell Distribution Width(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Lymphocyte Count(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Monocyte Count(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Eosinophil Count(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Basophil Count(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 Platelet Count(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 Mean Platelet Volume(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 Serum Urea 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 Blood Urea Nitrogen 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 Total Protein 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 Total Bilirubin 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 Fasting Glucose Concentration(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Fasting Insulin Concentration(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Total Cholesterol Concentration(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in High-Density Lipoprotein Cholesterol Concentration(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Low-Density Lipoprotein Cholesterol Concentration(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
- Change in Triglyceride Concentration(Phase-specific baseline and end of each 4-week intervention period, corresponding to Weeks 0, 4, 6, and 10.)
研究者
Justo Javier Pedroche Jimenez
Tenured scientist
Instituto de la Grasa