Sports NutritionPhase 4NCT05562401
Effect of Coconut Water on Hydration Status in Pediatric Population
A Phase 4 study testing Coconut Water and Oral Electrolytes in people with Sports Nutrition, run by Universidad de Colima at 1 site in Mexico.
Trial summary
Introduction: The dehydration is a very common problem that is often not identified. The pediatric population is more susceptible to dehydration due to its physiological characteristics. Read more about this study
- Who is it for?
- Ages 12 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutrition
- What is being tested?
- Coconut Water and Oral Electrolytes
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMexico
- Study dates
- 15 Oct 2021to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Students that belong to "Instituto Salesiano Fray Pedro de Gante".
- Those students who are 12 years old and under 18 years of age.
- The parent or guardian of the adolescent and the student himself must agree to participate and comply with the autographed authorization of the informed consent letter.
- The adolescent must be in good physical and mental health.
Who cannot join
- Adolescents who suffer from a chronic disease such as obesity, hypertension, DM, asthma, COPD, cancer, injuries or physical disabilities.
- That the adolescent is allergic to any component of the treatments.
- Elimination criteria:
- Adolescents who do not complete physical training sessions.
- That the adolescent presents a serious sports injury (fracture or sprain) during any of the physical exercise sessions.
- That the adolescent decides to withdraw once the practical research stage has begun.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Coconut Water Compared to Oral Electrolytes on Hydration Status in Adolescents Who Perform Physical Exercise: Randomized Clinical Trial, Double-blind
Introduction: The dehydration is a very common problem that is often not identified. The pediatric population is more susceptible to dehydration due to its physiological characteristics. Proper hydration is crucial for health since any degree of dehydration causes a reduction in physical and mental work capacity, hence the importance of preventing it by considering the type of drink. There are multiple beverage options, including industrial oral electrolytes (OE), on the other hand, coconut water (CW) has been studied as a natural alternative beverage with characteristics that can help maintain a state of euhydration. Objective: To determine if AC has a greater effect on hydration status than OE in adolescents who perform physical exercise. Material and methods: RCT, double blind. 34 subjects aged 13.02 ± 1.08 years were selected, assigned to treatment with either OE (Electrolit®) or CW. They received a weekly physical exercise session (4 weeks). Hydration was personalized (ml x kilograms of weight) and hydration was evaluated by Urine Specific Gravity (USG), Total Body Water (TBW) by bioimpedance and changes in body mass. Results:
Sesion 1 CW: Euhydrated (12) Dehydrated (5); OE: Euhydrated (8) Dehydrated (9); p value=0,16
Read more
Sesion 2 CW: Euhydrated (12) Dehydrated (5); OE: Euhydrated (7) Dehydrated (10); p value=0,08
Sesion 3 CW: Euhydrated (13) Dehydrated (4); OE: Euhydrated (13) Dehydrated (4); p value=1,00
Sesion 4 CW: Euhydrated (16) Dehydrated (1); OE: Euhydrated (8) Dehydrated (9); p value=0,007*
Conclusion: AC and OE have the same effect on hydration levels in adolescents who perform physical exercise.
Read the detailed description
- For current epidemiological reasons of Covid-19, an increase of 30% of losses has been considered already established in the sample size, giving a total of 22 participants per group (44 in total). For the same reason, two groups of 22 participants (11 experimental and 11 controls) will be divided in order to reduce the population and the risk of contagion, following the health protocols established by the institution mentioned in Annex 2. The type of randomization to be used in the study will be based on the assigned treatment (A / B) by the balanced block method. This method consists of assembling a series of blocks, made up of a certain number of cells, in which the different types of treatment are included. The number of blocks will be determined by the number of participants to be included and the number of cells that it has been decided to include in each block, so in the present study 12 blocks with four treatment cells will be placed, giving a total of 44 treatments to the same as the number of study subjects. Each block will contain in each cell one of the treatment alternatives and within each block there must be a balanced number of possible treatments. Treatments A and B will be written in blocks (22 with treatment A and 22 with treatment B). The randomization will be carried out by a person external to the study and the same person will be the one who will randomly assign the treatments in the blocks and the numbering of each block. They will be summoned to 12:00 noon on Monday or Tuesday only according to the group assigned to start with the collection of personal data (Annex 3) and a mental test called Psychological Characteristics related to Sports Performance (CPRD) (Annex 4) which will be applied by an expert in the area of psychology, in addition, if training is required for the application of the test, the main researcher will be trained to be able to perform it properly.
- After taking personal data, hydrating drinks will be administered immediately before training (7 ml x kg of weight) 4 hours before. At 2:00 p.m., your corresponding hydrating drink (4 ml x kg of weight) will be administered again. Each participant will have a 600 ml graduated glass that will be granted by the researcher to keep track of the drink administered at the different times of each session.
- Immediately afterwards, the anthropometry and urine sample will be taken. To record body mass, the protocol developed by the International Society for the Advancement of Kinanthropometry (ISAK) will be followed. The study subjects will be weighed in sports shorts and barefoot before starting physical exercise, having been told that, in the case of urinating or defecating, they should do so before the initial weigh-in. Simultaneously with taking the body mass, the% ACT will be determined by electrical bioimpedance. To record body mass and% of ACT water, the Tanita BC-533 bioimpedance scale will be used with a reliability of 97%, precision of 0.1kg and with a measuring range of 0-150kg.
- Once the anthropometry and urine sample have been taken, a 200 ml dose will be administered immediately before exercise (10-15) min.
- They will continue with the physical exercise protocol which will receive a physical exercise session per week (Tuesdays), with a duration of 1 hour and 15 minutes each session. The exercise sessions will be carried out in the Domingo Savio sports fields and will be taught by the principal investigator who has worked as a sports coach in the soccer area for 3 years, in addition to being trained for this purpose in the same institution where he was will carry out the study. Days prior to the start of the practical execution of the protocol, parents and selected students will be summoned to a meeting in order to explain the dynamics that will take place. The physical exercise sessions will consist of 4 parts:
- The first part of the workout will consist of a 10 minute warm-up and stretching to increase your basal HR and prepare the body for the next high intensity stages and prevent injuries in teens. The warm-up will have a break of 5 minutes and hydration of 2 ml x kg of weight.
- This second part will take place in 12 min of continuous jogging around the field at an average pace, aiming to do one lap every 1 minute 36 seconds, giving a total of 7 and a half laps to the soccer field (Cooper's Test). 8 min rest for the total recovery of energy systems and hydration of 2 ml x kg of weight.
- In the second part of the training, the adolescents must run from one line to another, twenty meters apart, at the pace set by a tape. This race pace will increase every minute. Subjects start the test at a speed of 8 km / hr, the first minute increases to 9 km / hr and thereafter, each minute increases the pace ½ km / hr. The test ends when they cannot keep up with the pace set (Test de course Navette). Approximate time 10 min with 8 min rest and hydration of 2 ml x kg of weight.
- In this last part of the training session, it is a type of exercise based on tabatas, which consists of performing 8 different exercises for 20 seconds per 10 seconds of rest to the rhythm of the marked music, giving a time of 4 minutes per tabata. .2 tabatas will be made with an intermediate rest of 3 min between each tabata and hydration of 2 ml x kg of weight.
- At the end of this last stage of the training session, anthropometry and information collection will be taken where the percentage of weight change, body composition with bioimpedance will be determined before starting the final hydration, since if it is done at the In reverse, it is very likely that no one will come out in a state of dehydration. After the anthropometry, they will be administered the corresponding post-exercise hydration (1.5 ml x kg of weight) and the urine sample will be collected. In the event that a subject has not urinated due to dehydration, their sterilized bottle will be taken home and the head of research will be notified immediately for its proper conservation or transport. The calculation of the percentage of lost weight will be calculated using the following formula:% Weight Loss or Dehydration = [(Initial Weight - Final Weight) / Initial Weight] x 100.
- As a final point, the data obtained before the exercise will be compared with the data obtained after the exercise, where the euhydration cut-off points will be analyzed to categorize the subject as dehydrated or euhydrated. An effective drink (CW or OE) will be considered when any 2 or more indicators (GEO, ACT or Body Mass) are consistent with the euhydration thresholds.
- Conditions
- Sports Nutrition
- Being tested
- Coconut Water, Oral Electrolytes
- Keywords
- Dehydration, Pediatric population, Coconut water, Sport drink, Hydration status, Physical exercise
- Medical subject headings
- Dehydration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut WaterDevice
Coconut water is the clear fluid inside the coconut, has natural electrolytes such as potassium, sodium and manganese.
Oral ElectrolytesDrug
Is be considered a drug that not require medical prescrption and containing water, carbohydrates and electrolytes.
| Study group | Role | What they receive |
|---|---|---|
| Coconut Water | Experimental | To determine if Coconut Water is more effective on hydration status than oral electrolytes in adolescents who perform physical exercise of aerobic competition. Receives: Device: Coconut Water |
| Oral Electrolytes | Active comparator | To determine if Coconut Water is more effective on hydration status than oral electrolytes in adolescents who perform physical exercise of aerobic competition. Receives: Drug: Oral Electrolytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Effect of AC vs EO on Hydration Status in Adolescents Who Perform Physical Exercise of Aerobic Competition.
The independent variable is dichotomous and is classified as:
A for coconut water and B for oral electrolytes. will be measured in milliliters.
The dependient variable is dichotomus and is classified as:
- Euhydrated
- Dehydrated
It will be classified as euhydrated or dehydrated when any 2 or more indicators are consistent with the euhydration or dehydration cut-off points, as the case may be.
Measured: 4 weeks
Secondary outcomes (4)
Number of Participants With Dehydration Event After Exercise and Assigned Treatment Evaluated by Water Loss Related to Body Mass.
The change in body mass will be measured in kg indicating dehydration in a loss equal to or greater than 5 percent of initial weight through the principle that 1g of weight lost is equivalent to 1ml of water lost.
Measured: 4 weeks
Number of Participants With a Dehydration Event After Exercise and the Assigned Treatment Evaluated by the Percentage of Water Lost by Bioelectrical Impedance.
The electrical bioimpedance will measure the body water percentage before and after, indicating if the participant had the event of dehydration after the treatment when there was a loss of water equal to or greater than 2%.
Measured: 4 weeks
Number of Participants With Post-exercise Dehydration Event and Assigned Treatment Assessed by Urine Specific Gravity in g/Cubic cm.
The level of light refraction in the urine of the subjects will be measured before exercise to ensure their state of euhydration and at the end the changes of the new urine sample will be seen post exercise and hydration. The specific gravity of urine will be expressed in g/cm3.
Measured: 4 weeks
Number of Participants With Post-exercise Dehydration Event in Both Assigned Treatments Assessed by Body Mass, Bioelectrical Impedance, and Urine Specific Gravity Using Chi-square or T-test.
The results of each subject will be analyzed and both groups (coconut water or sports drink) will be compared to determine the hydration effect of the drinks used used by chi square or t tests.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start15 Oct 2021
- Primary completion30 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sports NutritionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of subjects will be formed that will be randomized by the type of treatment they will receive, which will be the same during the 4 interventions of the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Colima
- Sponsor type
- University, hospital or other
- Collaborators
- Carmen Alicia Sanchez Ramirez, Yunue Flores Ruelas, Alexis Adan Lopez Maria
- Responsible party
- Principal investigator, Fabian Rojas Larios, Universidad de Colima
- Investigators
- FABIAN ROJAS LARIOS, PhD, Study director, frojas@ucol.mxCarmen Alcia Sanchez Ramírez, PhD, Study director, carmen_sanchez@ucol.mx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562401
- Sponsor's protocol ID
- AALM
- Status last verified
- Feb 2025
- First submitted
- 15 Dec 2021
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the moment there is the hesitation to share the information until having preliminary results.
Publications
Saat M, Singh R, Sirisinghe RG, Nawawi M. Rehydration after exercise with fresh young coconut water, carbohydrate-electrolyte beverage and plain water. J Physiol Anthropol Appl Human Sci. 2002 Mar;21(2):93-104. doi: 10.2114/jpa.21.93.
PubMed 12056182Peart DJ, Hensby A, Shaw MP. Coconut Water Does Not Improve Markers of Hydration During Sub-maximal Exercise and Performance in a Subsequent Time Trial Compared with Water Alone. Int J Sport Nutr Exerc Metab. 2017 Jun;27(3):279-284. doi: 10.1123/ijsnem.2016-0121. Epub 2016 Oct 21.
PubMed 27768399
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coconut Water Compared to Oral Electrolytes on Hydration Status in Adolescents Who Perform Physical Exercise: Randomized Clinical Trial, Double-blind
- ClinicalTrials.gov ID
- NCT05562401
- Acronym / sponsor ID
- AALM
- Conditions
- Sports Nutrition
- Keywords
- Dehydration, Pediatric population, Coconut water, Sport drink, Hydration status, Physical exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad de ColimaUniversity, hospital or other
- Collaborators
- Carmen Alicia Sanchez Ramirez, Yunue Flores Ruelas, Alexis Adan Lopez Maria
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: The dehydration is a very common problem that is often not identified. The pediatric population is more susceptible to dehydration due to its physiological characteristics. Proper hydration is crucial for health since any degree of dehydration causes a reduction in physical and mental work capacity, hence the importance of preventing it by considering the type of drink. There are multiple beverage options, including industrial oral electrolytes (OE), on the other hand, coconut water (CW) has been studied as a natural alternative beverage with characteristics that can help maintain a state of euhydration. Objective: To determine if AC has a greater effect on hydration status than OE in adolescents who perform physical exercise. Material and methods: RCT, double blind. 34 subjects aged 13.02 ± 1.08 years were selected, assigned to treatment with either OE (Electrolit®) or CW. They received a weekly physical exercise session (4 weeks). Hydration was personalized (ml x kilograms of weight) and hydration was evaluated by Urine Specific Gravity (USG), Total Body Water (TBW) by bioimpedance and changes in body mass. Results:
Sesion 1 CW: Euhydrated (12) Dehydrated (5); OE: Euhydrated (8) Dehydrated (9); p value=0,16
Sesion 2 CW: Euhydrated (12) Dehydrated (5); OE: Euhydrated (7) Dehydrated (10); p value=0,08
Sesion 3 CW: Euhydrated (13) Dehydrated (4); OE: Euhydrated (13) Dehydrated (4); p value=1,00
Sesion 4 CW: Euhydrated (16) Dehydrated (1); OE: Euhydrated (8) Dehydrated (9); p value=0,007*
Conclusion: AC and OE have the same effect on hydration levels in adolescents who perform physical exercise.
Detailed description
- For current epidemiological reasons of Covid-19, an increase of 30% of losses has been considered already established in the sample size, giving a total of 22 participants per group (44 in total). For the same reason, two groups of 22 participants (11 experimental and 11 controls) will be divided in order to reduce the population and the risk of contagion, following the health protocols established by the institution mentioned in Annex 2. The type of randomization to be used in the study will be based on the assigned treatment (A / B) by the balanced block method. This method consists of assembling a series of blocks, made up of a certain number of cells, in which the different types of treatment are included. The number of blocks will be determined by the number of participants to be included and the number of cells that it has been decided to include in each block, so in the present study 12 blocks with four treatment cells will be placed, giving a total of 44 treatments to the same as the number of study subjects. Each block will contain in each cell one of the treatment alternatives and within each block there must be a balanced number of possible treatments. Treatments A and B will be written in blocks (22 with treatment A and 22 with treatment B). The randomization will be carried out by a person external to the study and the same person will be the one who will randomly assign the treatments in the blocks and the numbering of each block. They will be summoned to 12:00 noon on Monday or Tuesday only according to the group assigned to start with the collection of personal data (Annex 3) and a mental test called Psychological Characteristics related to Sports Performance (CPRD) (Annex 4) which will be applied by an expert in the area of psychology, in addition, if training is required for the application of the test, the main researcher will be trained to be able to perform it properly.
- After taking personal data, hydrating drinks will be administered immediately before training (7 ml x kg of weight) 4 hours before. At 2:00 p.m., your corresponding hydrating drink (4 ml x kg of weight) will be administered again. Each participant will have a 600 ml graduated glass that will be granted by the researcher to keep track of the drink administered at the different times of each session.
- Immediately afterwards, the anthropometry and urine sample will be taken. To record body mass, the protocol developed by the International Society for the Advancement of Kinanthropometry (ISAK) will be followed. The study subjects will be weighed in sports shorts and barefoot before starting physical exercise, having been told that, in the case of urinating or defecating, they should do so before the initial weigh-in. Simultaneously with taking the body mass, the% ACT will be determined by electrical bioimpedance. To record body mass and% of ACT water, the Tanita BC-533 bioimpedance scale will be used with a reliability of 97%, precision of 0.1kg and with a measuring range of 0-150kg.
- Once the anthropometry and urine sample have been taken, a 200 ml dose will be administered immediately before exercise (10-15) min.
- They will continue with the physical exercise protocol which will receive a physical exercise session per week (Tuesdays), with a duration of 1 hour and 15 minutes each session. The exercise sessions will be carried out in the Domingo Savio sports fields and will be taught by the principal investigator who has worked as a sports coach in the soccer area for 3 years, in addition to being trained for this purpose in the same institution where he was will carry out the study. Days prior to the start of the practical execution of the protocol, parents and selected students will be summoned to a meeting in order to explain the dynamics that will take place. The physical exercise sessions will consist of 4 parts:
- The first part of the workout will consist of a 10 minute warm-up and stretching to increase your basal HR and prepare the body for the next high intensity stages and prevent injuries in teens. The warm-up will have a break of 5 minutes and hydration of 2 ml x kg of weight.
- This second part will take place in 12 min of continuous jogging around the field at an average pace, aiming to do one lap every 1 minute 36 seconds, giving a total of 7 and a half laps to the soccer field (Cooper's Test). 8 min rest for the total recovery of energy systems and hydration of 2 ml x kg of weight.
- In the second part of the training, the adolescents must run from one line to another, twenty meters apart, at the pace set by a tape. This race pace will increase every minute. Subjects start the test at a speed of 8 km / hr, the first minute increases to 9 km / hr and thereafter, each minute increases the pace ½ km / hr. The test ends when they cannot keep up with the pace set (Test de course Navette). Approximate time 10 min with 8 min rest and hydration of 2 ml x kg of weight.
- In this last part of the training session, it is a type of exercise based on tabatas, which consists of performing 8 different exercises for 20 seconds per 10 seconds of rest to the rhythm of the marked music, giving a time of 4 minutes per tabata. .2 tabatas will be made with an intermediate rest of 3 min between each tabata and hydration of 2 ml x kg of weight.
- At the end of this last stage of the training session, anthropometry and information collection will be taken where the percentage of weight change, body composition with bioimpedance will be determined before starting the final hydration, since if it is done at the In reverse, it is very likely that no one will come out in a state of dehydration. After the anthropometry, they will be administered the corresponding post-exercise hydration (1.5 ml x kg of weight) and the urine sample will be collected. In the event that a subject has not urinated due to dehydration, their sterilized bottle will be taken home and the head of research will be notified immediately for its proper conservation or transport. The calculation of the percentage of lost weight will be calculated using the following formula:% Weight Loss or Dehydration = [(Initial Weight - Final Weight) / Initial Weight] x 100.
- As a final point, the data obtained before the exercise will be compared with the data obtained after the exercise, where the euhydration cut-off points will be analyzed to categorize the subject as dehydrated or euhydrated. An effective drink (CW or OE) will be considered when any 2 or more indicators (GEO, ACT or Body Mass) are consistent with the euhydration thresholds.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two groups of subjects will be formed that will be randomized by the type of treatment they will receive, which will be the same during the 4 interventions of the study.
| Arm | Type | Receives |
|---|---|---|
| Coconut Water | Experimental | Device: Coconut WaterTo determine if Coconut Water is more effective on hydration status than oral electrolytes in adolescents who perform physical exercise of aerobic competition. |
| Oral Electrolytes | Active comparator | Drug: Oral ElectrolytesTo determine if Coconut Water is more effective on hydration status than oral electrolytes in adolescents who perform physical exercise of aerobic competition. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Students that belong to "Instituto Salesiano Fray Pedro de Gante".
- Those students who are 12 years old and under 18 years of age.
- The parent or guardian of the adolescent and the student himself must agree to participate and comply with the autographed authorization of the informed consent letter.
- The adolescent must be in good physical and mental health.
Key exclusion criteria (6 listed)
- Adolescents who suffer from a chronic disease such as obesity, hypertension, DM, asthma, COPD, cancer, injuries or physical disabilities.
- That the adolescent is allergic to any component of the treatments.
- Adolescents who do not complete physical training sessions.
- That the adolescent presents a serious sports injury (fracture or sprain) during any of the physical exercise sessions.
- That the adolescent decides to withdraw once the practical research stage has begun.
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 |
|---|---|---|
| Coconut WaterCoconut water is the clear fluid inside the coconut, has natural electrolytes such as potassium, sodium and manganese. | Device | Coconut Water |
| Oral ElectrolytesIs be considered a drug that not require medical prescrption and containing water, carbohydrates and electrolytes. | Drug | Oral Electrolytes |
Primary outcome
To Determine the Effect of AC vs EO on Hydration Status in Adolescents Who Perform Physical Exercise of Aerobic Competition.
Time frame: 4 weeks
The independent variable is dichotomous and is classified as: A for coconut water and B for oral electrolytes. will be measured in milliliters. The dependient variable is dichotomus and is classified as: 1. Euhydrated 2. Dehydrated It will be classified as euhydrated or dehydrated when any 2 or more indicators are consistent with the euhydration or dehydration cut-off points, as the case may be.
4 secondary outcomes
Number of Participants With Dehydration Event After Exercise and Assigned Treatment Evaluated by Water Loss Related to Body Mass.
Time frame: 4 weeks
Number of Participants With a Dehydration Event After Exercise and the Assigned Treatment Evaluated by the Percentage of Water Lost by Bioelectrical Impedance.
Time frame: 4 weeks
Number of Participants With Post-exercise Dehydration Event and Assigned Treatment Assessed by Urine Specific Gravity in g/Cubic cm.
Time frame: 4 weeks
Number of Participants With Post-exercise Dehydration Event in Both Assigned Treatments Assessed by Body Mass, Bioelectrical Impedance, and Urine Specific Gravity Using Chi-square or T-test.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12056182Saat M, Singh R, Sirisinghe RG, Nawawi M. Rehydration after exercise with fresh young coconut water, carbohydrate-electrolyte beverage and plain water. J Physiol Anthropol Appl Human Sci. 2002 Mar;21(2):93-104. doi: 10.2114/jpa.21.93.
- Background: PubMed 27768399Peart DJ, Hensby A, Shaw MP. Coconut Water Does Not Improve Markers of Hydration During Sub-maximal Exercise and Performance in a Subsequent Time Trial Compared with Water Alone. Int J Sport Nutr Exerc Metab. 2017 Jun;27(3):279-284. doi: 10.1123/ijsnem.2016-0121. Epub 2016 Oct 21.
- Individual participant dataSharing planned: No. At the moment there is the hesitation to share the information until having preliminary results.
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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.
FABIAN ROJAS LARIOS, PhD study director
frojas@ucol.mx
Carmen Alcia Sanchez Ramírez, PhD study director
carmen_sanchez@ucol.mx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coconut Water and Oral Electrolytes in people with Sports Nutrition, run by Universidad de Colima at 1 site in Mexico.
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 4 inclusion and 6 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 21 Feb 2025. 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 Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine the Effect of AC vs EO on Hydration Status in Adolescents Who Perform Physical Exercise of Aerobic Competition. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562401, which also lists 2 linked publications.
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 21 Feb 2025.