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| Name | Class |
|---|---|
| Carmen Alicia Sanchez Ramirez | UNKNOWN |
| Yunue Flores Ruelas | UNKNOWN |
| Alexis Adan Lopez Maria | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coconut Water | Device | Coconut water is the clear fluid inside the coconut, has natural electrolytes such as potassium, sodium and manganese. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Elimination criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FABIAN ROJAS LARIOS, PhD | frojas@ucol.mx | Study Director |
| Carmen Alcia Sanchez Ramírez, PhD | carmen_sanchez@ucol.mx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexis Adan Lopez Maria | Colima | 28040 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12056182 | Background | 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. | |
| 27768399 | Background | Peart 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. |
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At the moment there is the hesitation to share the information until having preliminary results.
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34 healthy adolescents from 12 to 17 years of age were selected by simple sampling, of which 8 subjects were excluded due to CoVid-19 and 2 decided not to participate, later they were randomly assigned to a treatment group using the balanced block method.
That the adolescent is a student belonging to the private institution ISFPG. That the adolescent perform competitive physical exercise of an aerobic type. Those students who are 12 years old and who are under 18 years old. The parent or guardian of the adolescent and the student himself must agree to participate and comply with The autograph authorization of the informed consent letter.
The adolescent must be in good physical (Annex 2) and mental (Annex 3) health.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coconut Water | To determine if Coconut Water is more effective on hydration status than oral electrolytes in adolescents who perform physical exercise of aerobic competition. Coconut Water: Coconut water is the clear fluid inside the coconut, has natural electrolytes such as potassium, sodium and manganese. |
| FG001 | Oral Electrolytes | To determine if Coconut Water is more effective on hydration status than oral electrolytes in adolescents who perform physical exercise of aerobic competition. OE: It is considered a medicine by the general health law that does not require a prescription and can be sold in any establishment that is not a pharmacy. Is an industrialized drink that containing water, carbohydrates, electrolytes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coconut Water | To determine if Coconut Water is more effective on hydration status than Oral Electrolytes in adolescents who perform aerobic physical exercise. Coconut Water: Coconut water is the clear fluid inside the coconut, has natural electrolytes such as potassium, sodium and manganese. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
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. | Posted | Number | Number participants euhydrated | 4 weeks |
|
4 weeks
The adverse event that could have occurred in addition to finishing the exercise session dehydrated would be: sports injury.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coconut Water | To determine if Coconut Water is more effective on hydration status than oral electrolytes in adolescents who perform physical exercise of aerobic competition. Coconut Water: Coconut water is the clear fluid inside the coconut, has natural electrolytes such as potassium, sodium and manganese. |
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Some variables that could affect hydration levels and that, for economic reasons or beyond the control of the researchers in charge, could not be controlled or included in the study. The weather was an environmental factor that could not be controlled due to the facilities where the study was conducted. The gold standard of hydration was not applied for reasons of practicality and economy, in addition, hydration levels change in a matter of minutes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fabian Rojas Larios | UColima | 3121206804 | frojas@ucol.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 15, 2025 | Jan 16, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004573 | Electrolytes |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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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.
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The hydrating drinks will be placed in containers labeled as treatments 1 and 2 by a person in charge external to the project, where neither study subjects nor the main researcher will know the type of drink they will be receiving because both will have the same or similar appearance and taste.
| Oral Electrolytes | Drug | Is be considered a drug that not require medical prescrption and containing water, carbohydrates and electrolytes. |
|
| 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%. | 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. | 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. | 4 weeks |
| Oral Electrolytes |
To determine if Coconut Water is more effective on hydration status than Oral Electrolytes in adolescents who perform aerobic physical exercise. Oral electrolytes: It is considered a medicine by the general health law that does not require a prescription and can be sold in any establishment that is not a pharmacy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| OG001 | Oral Electrolytes | To determine if Coconut Water is more effective on hydration status than Oral Electrolytes in adolescents who perform aerobic physical exercise. Oral electrolytes: It is considered a medicine by the general health law that does not require a prescription and can be sold in any establishment that is not a pharmacy. |
|
|
| Secondary | 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. | Not Posted | Dec 2024 | 4 weeks | Participants |
| Secondary | 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%. | Not Posted | Dec 2024 | 4 weeks | Participants |
| Secondary | 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. | Not Posted | Dec 2024 | 4 weeks | Participants |
| Secondary | 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. | Not Posted | Dec 2024 | 4 weeks | Participants |
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Oral Electrolytes | To determine if Coconut Water is more effective on hydration status than oral electrolytes in adolescents who perform physical exercise of aerobic competition. Oral Electrolytes: Is be considered a drug that not require medical prescrption and containing water, carbohydrates and electrolytes. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |