Clinical Trial to Evaluate the Efficacy of a Sport Drink After High-intensity Aerobic Exercise

NCT05352724 | Completed

• 1 other identifier: Elit. Recov
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hydration; Blood Glucose; Sport Recovery; Microbiota

Outcome Measures

Primary Outcomes (11)

• Number and percentage of participants with changes in blood parameters of hydration and recovery: Complete Blood Count

  Changes in complete blood count parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Sodium (mEq/L)

  Changes in blood sodium parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Potassium (mEq/L)

  Changes in blood potassium parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Chlorine (mEq/L)

  Changes in blood chlorine parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Creatine kinase (mg/dL)

  Changes in blood creatine kinase parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Aldolase (U/L)

  Changes in blood aldolase parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Lactate (mg/dL)

  Changes in blood lactate parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Osmolality (mOsm/Kg)

  Changes in blood osmolality parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: AST (U/L)

  Changes in blood AST parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Urea (mg/dL)

  Changes in blood urea parameters at weeks 2 and 4

  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 blood parameters of hydration and recovery: Creatinine (mg/dL)

  Changes in blood creatinine parameters at weeks 2 and 4

  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.

Secondary Outcomes (5)

• 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 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 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 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]

• 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]

Study Arms (3)

Hydration drink A

EXPERIMENTAL

Water with electrolytes and glucose 625 ml 3 times a week for 4 weeks, during exercise

Dietary Supplement: Hydration drink

Hydration drink B

ACTIVE COMPARATOR

Water with electrolytes and calorie-free sweetener 625 ml 3 times a week for 4 weeks, during exercise

Dietary Supplement: Hydration drink

Hydration drink C

PLACEBO COMPARATOR

Water with flavoring and coloring 625 ml 3 times a week for 4 weeks, during exercise

Dietary Supplement: Hydration drink

Interventions

Hydration drink DIETARY_SUPPLEMENT

Intake of the different hydrating drinks for 4 weeks 3 times a week during sports practice

Hydration drink A; Hydration drink B; Hydration drink C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioithas SL: lead

Study Sites (1)

Grupo MiBioPath. Univesidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The clinical study has a randomized, double-blind, placebo-controlled design. The patients on the list will be randomized to each of the two intervention groups in a 1:1:1 ratio (33% probability for intervention group 1, 33% for intervention group 2 and 33% for the placebo group)

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 29, 2022
• Study Start: October 20, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 24, 2023
• Last Updated: April 25, 2023

Record last verified: 2022-04

Locations

ES (1)