Effects of β-alanine and Sodium Bicarbonate Supplementation on Physical Capacity and Biochemical Markers Concentrations

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка BA and SB supplementation
  Assigned Interventions: * Beta-alanine (BA) * Sodium bicarbonate (SB) Description: • Participants receive beta-alanine and sodium bicarbonate Intervention list \& supplementation details: 1. Beta-alanine (BA) * Form: Gelatin capsules * Substance: Pure beta-alanine * Daily dose: 6.4 g/day * Dosing schedule: Four equal servings taken with meals (breakfast, lunch, snack, dinner) * Supplementation period: days 1 to 28 2. Sodium bicarbonate (SB) * Form: Gelatin capsules *
• Пищевая добавка BA and PL2 supplementation
  Participants in this intervention group will undergo chronic supplementation with beta-alanine (BA) and an inert placebo (PL2) matched to the sodium bicarbonate (SB) protocol. * Beta-alanine (pure, in gelatin capsules) will be administered at a total daily dose of 6.4 g, divided into four servings taken with meals, over a period of 28 consecutive days. * PL2 (placebo matched to SB, in gelatin capsules) will be administered from Day 21 to Day 28 of beta-alanine supplementation, at a daily dose o
• Пищевая добавка PL1 and SB supplementation
  Assigned Interventions: * Placebo matched to BA (PL1) * Sodium bicarbonate (SB) Description: • Participants receive only sodium bicarbonate as the active compound and placebo capsules matching the BA protocol. Intervention list \& supplementation details: 1. Placebo matched to BA (PL1) * Form: Gelatin capsules * Substance: Inert substance matched in appearance and dosing schedule to BA * Daily dose: 6.4 g/day * Dosing schedule: Four equal servings taken with meals (breakfast, l
• Пищевая добавка PL1 and PL2 supplementation
  Assigned Interventions: * Placebo matched to BA (PL1) * Placebo matched to SB (PL2) Description: • Participants receive two matched placebos. Intervention list \& supplementation details: 1. Placebo matched to BA (PL1) * Form: Gelatin capsules * Substance: Inert substance matched in appearance and dosing schedule to BA * Daily dose: 6.4 g/day * Dosing schedule: Four equal servings taken with meals (breakfast, lunch, snack, dinner) * Supplementation period: days 1 to 28 2. Pl

Первичные конечные точки

• Changes in anaerobic capacity during Wingate Anaerobic Test (WAnT) [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]
• Changes in Countermovement Jump (CMJ) performance [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]
• Changes in aerobic capacity during incremental cycling test (ICT) [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]
• Changes in blood bicarbonate, base excess, anion gap, and lactate concentrations [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]
• Changes in hydrogen ion concentration [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]

Вторичные конечные точки (12)

• Analysis of dietary energy intake [Срок оценки: 48 h before the first study visit and the second study visit after 28 days of intervention.]
• Analysis of dietary macronutrient intake [Срок оценки: 48 h before the first study visit and the second study visit after 28 days of intervention.]
• Changes in rate of perceived exertion [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]
• Changes in heart rate [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]
• Changes in gastrointestinal symptoms [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]
• Changes in platelets distribution width and platelets large cell ratio [Срок оценки: 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 [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]
• Changes in hematocrit [Срок оценки: 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 [Срок оценки: During the first study visit on the first day and during the second study visit after 28 days of intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• Department of Sports Dietetics, Poznan University of Physical Education Poznań — Poznan

Публикации

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. PMID 7154893
• Jeukendrup AE, Vet-Joop K, Sturk A, Stegen JH, Senden J, Saris WH, Wagenmakers AJ. Relationship between gastro-intestinal complaints and endotoxaemia, cytokine release and the acute-phase reaction during and after a long-distance triathlon in highly trained men. Clin Sci (Lond). 2000 Jan;98(1):47-55. PMID 10600658

Идентификаторы

NCT: NCT07092930 · ZDS2025_0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗