Ignite Creation Date:
2024-05-06 @ 6:10 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05562401
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2021-12-15
Brief Title:
Effect of Coconut Water on Hydration Status in Pediatric Population
Sponsor:
Universidad de Colima
Organization:
Universidad de Colima
Study Overview
Official Title:
Effect of Coconut Water Compared to Oral Electrolytes on Hydration Status in Adolescents Who Perform Physical Exercise Randomized Clinical Trial Double-blind
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 1302 108 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 There were no significant differences in hydration in the first 3 exercise sessions p005 however in the last session there was a significant difference between treatments p0003 Conclusion AC and OE have the same effect on hydration levels in adolescents who perform physical exercise
Detailed Description:
1 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 1200 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
2 After taking personal data hydrating drinks will be administered immediately before training 7 ml x kg of weight 4 hours before At 200 pm 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
3 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 01kg and with a measuring range of 0-150kg
4 Once the anthropometry and urine sample have been taken a 200 ml dose will be administered immediately before exercise 10-15 min
5 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
1 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
2 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 Coopers Test 8 min rest for the total recovery of energy systems and hydration of 2 ml x kg of weight
3 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
4 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
6 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 15 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
7 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
2 After taking personal data hydrating drinks will be administered immediately before training 7 ml x kg of weight 4 hours before At 200 pm 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
3 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 01kg and with a measuring range of 0-150kg
4 Once the anthropometry and urine sample have been taken a 200 ml dose will be administered immediately before exercise 10-15 min
5 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
1 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
2 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 Coopers Test 8 min rest for the total recovery of energy systems and hydration of 2 ml x kg of weight
3 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
4 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
6 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 15 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
7 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None