HydrationNCT05352724
Clinical Trial to Evaluate the Efficacy of a Sport Drink After High-intensity Aerobic Exercise
A study testing Hydration drink in people with Hydration and Blood Glucose, run by Bioithas SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration, Blood Glucose, Sport Recovery
- What is being tested?
- Hydration drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2022to 24 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Serious allergic diseases
- Inability to communicate with the investigator
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Spain1 site
Grupo MiBioPath. Univesidad Católica San Antonio de Murcia
Guadalupe, Murcia, 30107
About this study
Official title: 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
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.
Read more
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.
Read the 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 .
- Conditions
- Hydration, Blood Glucose, Sport Recovery, Microbiota
- Being tested
- Hydration drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration drinkDietary supplement
Intake of the different hydrating drinks for 4 weeks 3 times a week during sports practice
| Study group | Role | What they receive |
|---|---|---|
| Hydration drink A | Experimental | Water with electrolytes and glucose 625 ml 3 times a week for 4 weeks, during exercise Receives: 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 Receives: 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 Receives: Dietary Supplement: Hydration drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Changes in urine osmolality parameters at weeks 2 and 4
Measured: 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
Changes in the Borg Scale of perceived exertion CR-10 score at weeks 2 and 4. Scores on this scale range from 0 to 10 from lowest to highest perceived exertion.
Measured: 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)
Changes in blood glucose parameters at weeks 2 and 4.
Measured: 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)
BMI in kg/m^2 changes at weeks 2 and 4. Weight and height will be combined to report BMI in kg/m^2.
Measured: 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
Changes in alpha diversity, beta diversity and microbiota composition at week 4
Measured: Initial sample collection at week 0 [T0] and final at week 4 [T2]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start20 Oct 2022
- Primary completion1 Mar 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioithas SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352724
- Sponsor's protocol ID
- Elit. Recov
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05352724
- Acronym / sponsor ID
- Elit. Recov
- Conditions
- Hydration, Blood Glucose, Sport Recovery, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bioithas SLIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Hydration drink A | Experimental | Dietary Supplement: Hydration drinkWater with electrolytes and glucose 625 ml 3 times a week for 4 weeks, during exercise |
| Hydration drink B | Active comparator | Dietary Supplement: Hydration drinkWater with electrolytes and calorie-free sweetener 625 ml 3 times a week for 4 weeks, during exercise |
| Hydration drink C | Placebo comparator | Dietary Supplement: Hydration drinkWater with flavoring and coloring 625 ml 3 times a week for 4 weeks, during exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydration drinkIntake of the different hydrating drinks for 4 weeks 3 times a week during sports practice | Dietary supplement | Hydration drink A, Hydration drink B, Hydration drink C |
Primary outcome
Number and percentage of participants with changes in blood parameters of hydration and recovery: Complete Blood Count
Time frame: 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)
Time frame: 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: Potassium (mEq/L)
Time frame: 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: Chlorine (mEq/L)
Time frame: 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: Creatine kinase (mg/dL)
Time frame: 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)
Time frame: 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)
Time frame: 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: Osmolality (mOsm/Kg)
Time frame: 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: AST (U/L)
Time frame: 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)
Time frame: 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: Creatinine (mg/dL)
Time frame: 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
5 secondary outcomes
Number and percentage of participants with changes in urinary hydration parameters: Urine osmolality (mOsm/kg)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Initial sample collection at week 0 [T0] and final at week 4 [T2]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration drink in people with Hydration and Blood Glucose, run by Bioithas SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants with changes in blood parameters of hydration and recovery: Complete Blood Count (time frame: 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.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.