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临床试验/NCT07092930
NCT07092930招募中3 期

Evaluation of the Synergistic Effect of β-alanine and Sodium Bicarbonate Supplementation on Physical Capacity and Blood Biochemical Markers Concentrations in Trained Female Basketball Players

Poznan University of Physical Education2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月1日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Changes in anaerobic capacity during Wingate Anaerobic Test (WAnT)

研究概览

简要总结

This randomized, double-blind, placebo-controlled, parallel-group study aims to evaluate the potential synergistic effect of beta-alanine (BA) and sodium bicarbonate (SB) supplementation, compared to their separate administration or placebo (PL), on physical performance and selected blood biochemical markers in highly trained female basketball players.

详细描述

Beta-alanine (BA) and sodium bicarbonate (SB) are commonly proposed as ergogenic aids due to their potential to enhance intracellular (BA) and extracellular (SB) buffering capacities, thereby improving physical performance. However, there is a lack of evidence regarding their potential synergistic effects, particularly in female athletes. Existing studies have primarily focused on male participants, despite emerging evidence suggesting sex-specific physiological responses to supplementation. Furthermore, research shows that females exhibit a high willingness to participate in scientific studies, underlining the importance of including female cohorts in sports supplementation research. To date, no randomized, double-blind, placebo-controlled trials have examined the combined and separate effects of BA and SB using a four-arm design (BA+SB, BA+PL2, PL1+SB, PL1+ PL2). Only one study to date has focused on chronic SB supplementation, whereas the majority have used acute protocols. Additionally, there is a notable lack of data on the use of BA and SB in team sports such as basketball, where repeated high-intensity efforts are dominant. Therefore, this study aims to investigate the chronic effects of BA and SB supplementation (administered individually or in combination) on physical capacity and selected blood biochemical markers in highly trained female basketball players, using a randomized, double-blind, placebo-controlled, parallel-group design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • written consent to participate,
  • general good health condition,
  • a current medical clearance to practice sports,
  • training experience: at least 4 years,
  • minimum of 4 workout sessions (in the discipline covered by the study) a week.

排除标准

  • current injury,
  • any health-related contraindication,
  • declared general feeling of being unwell,
  • taking supplements, especially ergogenic supplements that modulate extra- and intracellular capacity 3 months prior to research (except taking protein and/or carbohydrate powders, isotonic drinks),
  • unwilling to follow the study protocol.

结局指标

主要结局

Changes in anaerobic capacity during Wingate Anaerobic Test (WAnT)

时间窗: During the first study visit on the first day and during the second study visit after 28 days of intervention.

Assessment of peak power (PP), average power (AP), minimum power (MP), power drop (PD) \[W (Watts)\] using the Monark 894E ergometer (measured before and after incremental cycling test (ICT)) before and after supplementation (BA - beta-alanine; SB - sodium bicarbonate; PL - placebo; with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).

Changes in hydrogen ion concentration

时间窗: During the first study visit on the first day and during the second study visit after 28 days of intervention.

Assessment of hydrogen ion concentration \[nmol/L\] measured in capillary blood at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).

Changes in aerobic capacity during incremental cycling test (ICT)

时间窗: During the first study visit on the first day and during the second study visit after 28 days of intervention.

Assessment of time to exhaustion \[s (seconds)\] during an incremental cycling test (ICT) using Ergoline E100P-K, measured before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).

Changes in Countermovement Jump (CMJ) performance

时间窗: During the first study visit on the first day and during the second study visit after 28 days of intervention.

Assessment of three consecutive countermovement jump (CMJ) heights \[cm (centimetres)\] using the Microgate system, measured at rest and after the entire exercise procedure, both before and after supplementation.

Changes in blood bicarbonate, base excess, anion gap, and lactate concentrations

时间窗: During the first study visit on the first day and during the second study visit after 28 days of intervention.

Assessment of bicarbonate, base excess, anion gap, lactate \[mmol/L\] measured in capillary blood at rest, after warm-up, and after the entire exercise procedure, before and after supplementation (with BA+SB, BA+PL2, PL1+SB, or PL1+PL2).

次要结局

  • Changes in platelets distribution width and platelets large cell ratio(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in urine erythrocytes and leukocytes(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Analysis of dietary energy intake(48 h before the first study visit and the second study visit after 28 days of intervention.)
  • Changes in urea and magnesium(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in body mass, fat-free mass and fat mass(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in lymphocytes, monocytes, granulocytes, red blood cells and platelets(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in mean corpuscular volume, mean platelet volume, red blood cell distribution width(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in creatinine(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in iron and unsaturated iron binding capacity(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in protein, glucose, ketones, urobilinogen, bilirubin(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in heart rate(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in gastrointestinal symptoms(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in total body water content(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in hemoglobin and mean corpuscular hemoglobin concentration(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in transferrin(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in urine specific gravity(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in urine luteinizing hormone and nitrite(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Analysis of dietary macronutrient intake(48 h before the first study visit and the second study visit after 28 days of intervention.)
  • Changes in rate of perceived exertion(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in hematocrit(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in mean corpuscular hemoglobin(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in alanine aminotransferase, aspartate aminotransferase, creatine kinase and lactate dehydrogenase(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in ferritin(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in potassium, sodium, ionized calcium, chloride, osmolality(During the first study visit on the first day and during the second study visit after 28 days of intervention.)
  • Changes in pH(During the first study visit on the first day and during the second study visit after 28 days of intervention.)

研究者

发起方
Poznan University of Physical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Krzysztof Durkalec-Michalski

Prof.

Poznan University of Physical Education

研究点 (2)

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