Clinical Trial to Evaluate the Efficacy of a Sport Drink After High-intensity Aerobic Exercise
Condition: Hydration; Blood Glucose; Sport Recovery; Microbiota
Study type: Interventional

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.
    

Detailed description: 
      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)

      In order to recruit volunteers, all interested subjects who meet the criteria below will be
      informed in detail about the study. Knowing in detail the characteristics of the study and
      the implications of their participation, the volunteers will be able to sign the informed
      consent if participants so wish. Before signing, volunteers will have ample time to review
      and consider the detailed information and ask the researcher questions if participants wish.
      The volunteer recruitment process will continue until the desired sample size is reached.

      Once the informed consent has been signed, a physician trained for the study will carry out
      the initial interview where it is verified that the subject meets all the inclusion criteria
      and none of the exclusion criteria, as well as her clinical history.

      The investigator will assign the participant the next participant number in the study and,
      according to a previously prepared randomization list, the treatment that will be received
      during the study will be assigned.

      At this initial visit, a physical examination will be performed that will include weight,
      height, body mass index (BMI), blood pressure, and heart rate. In addition, the volunteer
      will take a sample of peripheral blood, urine and feces.

      The value of perceived effort will be recorded according to the Borg CR-10 Scale in the last
      session of high-intensity aerobic exercise performed.

      Sufficient treatment will be provided for the entire study and the method of administration
      will be indicated.

      Prior hydration instructions will be indicated (consumption of 500 ml of water during the 2
      hours prior to the exercise session) for the control visits in weeks 2 and 4, with the aim
      that all participants attend in a fit state. optimal hydration.

      In this way, clinical baseline values will be obtained to be compared during follow-up
      visits.

      Exercise Session 1 (Visit 2/Week 2) Prior to the start of the session, the investigators will
      ensure that the volunteer has followed the hydration instructions given at the initial visit.

      In this second session, the first control will be carried out, coinciding with 2 weeks from
      the start of taking the product. In it, the training and hydration protocol will be applied
      using the different drinks under study and the Borg perceived exertion scale will be passed
      at the end of the exercise session.

      A measurement of body weight will be made before and after the physical exercise session.

      Between 30 and 60 minutes after the exercise routine, a peripheral blood sample will be
      taken. At 90 minutes, a urine sample will be collected. During the time elapsed between the
      end of the exercise session and the taking of samples, the volunteers will not be able to
      ingest food or drink. After 90 minutes and all the necessary samples have been taken, the
      participants will be able to drink and eat on demand.

      Exercise session 2. Final Visit (Visit 3/Week 4) The final visit will coincide with the end
      of the treatment and follow-up period.

      The same procedures will be carried out as in visit 2, but in this one, a stool sample will
      also be collected.

      The exercise sessions will be carried out under similar conditions: room, time of practice,
      temperature and humidity. These sessions will be controlled by the research staff and carried
      out by staff trained in training.

      These will follow the typical structure of high intensity aerobic training sessions, within
      the different disciplines that follow this methodology in fitness.

      In addition to complying with the premises in terms of typology, methodology, structure and
      general times (established in the training protocol), the control sessions in week 2 and 4
      will be exactly the same in relation to the specific design of the exercises and the times .
    

Intervention name(s): Hydration drink
Intervention type(s): Dietary Supplement
Intervention description(s): Intake of the different hydrating drinks for 4 weeks 3 times a week during sports practice
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other