Randomized, Double Blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Sports Drink on Hydration, Recovery and Glucemia Control After High-intensity Aerobic Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bioithas SL
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Number and percentage of participants with changes in blood parameters of hydration and recovery: Complete Blood Count
研究概览
简要总结
Although the general effectiveness of carbohydrate/electrolyte-based functional sports drinks on rehydration, recovery and sports performance has been widely demonstrated, there is controversy about the amounts, proportions and components that ensure the effectiveness of these products.
The present study intends to analyze the specific effects of the beverages to be studied on these parameters, taking into account their particular formulation.
Advances in research have allowed us to understand the importance of the intestinal microbiota on health, recovery and performance in sports. The consumption of functional drinks based on carbohydrates and electrolytes as supplementation is a constant in sports environments, with multiple studies on their properties, tolerance, safety and efficacy. However, there are no studies that analyze the effects of consuming these beverages and their interaction with the intestinal microbiota.
Therefore, in addition, it is intended to evaluate the changes in the microbiota, through analysis of stool samples, during the sustained consumption of the beverages under study.
详细描述
The clinical study has a randomized, double-blind, placebo-controlled design, in which the investigators want to evaluate and compare the effect of hydrating drink A, hydrating drink B, and hydrating drink C (placebo).
Hydration drink A. Water with electrolytes and glucose Hydration drink B. Water with electrolytes and calorie-free sweetener Hydrating drink C. Water with coloring and flavoring. placebo product
625ml containers, administered during sports practice in several intakes according to protocol. Total fluid intake will be 625 ml per training session, 3 times/week over a 4-week period
During the study, each volunteer will make 3 visits: visit 1 (before starting the consumption of the product), visit 2 or 1st control and visit 3 or 2nd control, at the end of the study.
Recruitment or initial interview (Visit 1/Week 0)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Neither the patients themselves nor the researchers involved in the study will know the assigned treatment, since these will be coded. The bottles will be labeled with these numbers and will not show distinctive signs of the treatment group. These lists will be kept by the head of the randomization center, and will be hidden from the study staff and participants. For each new inclusion, the researcher will have to contact the randomization center, which will obtain the assigned treatment code.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy trained athletes, between 18 and 65 years old, who practice high-intensity aerobic exercise between 3 and 5 times a week
- •Signature of the informed consent
- •Commitment in terms of compliance with data collection prior to the start of the study, hydration instructions prior to controlled exercise sessions and how to use the product
排除标准
- •Chronic disease that, in the opinion of the investigator, contraindicates participation in the study
- •Body Mass Index greater than 30
- •Acute illness in the last 3 months that has required treatment with steroids
- •Medical treatment or nutritional supplement that, in the opinion of the investigator, may interfere with the parameters under study
- •Drug use or mild alcoholism (daily consumption >20 g of alcohol in women and > 40 g in men)
- •Consumption of antibiotics and/or probiotics in the last 15 days
- •Serious allergic diseases
- •Inability to communicate with the investigator
- •Pregnancy or lactation
结局指标
主要结局
Number and percentage of participants with changes in blood parameters of hydration and recovery: Complete Blood Count
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in complete blood count parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Sodium (mEq/L)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood sodium parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: AST (U/L)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood AST parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Urea (mg/dL)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood urea parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Chlorine (mEq/L)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood chlorine parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Potassium (mEq/L)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood potassium parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Osmolality (mOsm/Kg)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood osmolality parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Creatine kinase (mg/dL)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood creatine kinase parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Aldolase (U/L)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood aldolase parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Lactate (mg/dL)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood lactate parameters at weeks 2 and 4
Number and percentage of participants with changes in blood parameters of hydration and recovery: Creatinine (mg/dL)
时间窗: At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session.
Changes in blood creatinine parameters at weeks 2 and 4
次要结局
- Number and percentage of participants with changes in the Borg Scale CR-10 score(At week 0 [T0], the baseline value of the last session of high-intensity aerobic exercise prior to the initial visit will be determined. In week 2 [T1] and 4 [T2] the values will be determined at the end of the exercise session.)
- Number and percentage of participants with changes in urinary hydration parameters: Urine osmolality (mOsm/kg)(At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined 90 minutes after the exercise session.)
- Number and percentage of participants with changes in blood glucose parameters (mg/dL)(At week 0 [T0] the fasting baseline value will be determined. In week 2 [T1] and 4 [T2] the values will be determined between 30 and 60 minutes after the exercise session)
- Number and percentage of participants with changes in their microbiota composition, alpha diversity and beta diversity, by sequencing the R16s gene of a stool sample(Initial sample collection at week 0 [T0] and final at week 4 [T2])
- Number and percentage of participants with body mass index changes (BMI)(Baseline fasting weight at week 0 [T0]. Weight before and after exercise sessions at week 2 [T1] and 4 [T2])