Effect of Coconut Water on Hydration Status in Pediatric Population

NCT05562401 | Completed Phase 4 Results DMC

• 1 other identifier: AALM
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sports Nutrition

Keywords

Dehydration; Pediatric population; Coconut water; Sport drink; Hydration status; Physical exercise

Outcome Measures

Primary Outcomes (1)

• 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: 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 weeks

Secondary Outcomes (4)

• Number of Participants With Dehydration Event After Exercise and Assigned Treatment Evaluated by Water Loss Related to Body Mass.

  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.

  4 weeks

• Number of Participants With Post-exercise Dehydration Event and Assigned Treatment Assessed by Urine Specific Gravity in g/Cubic cm.

  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.

  4 weeks

Study Arms (2)

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.

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.

Drug: Oral Electrolytes

Interventions

Coconut Water DEVICE

Coconut water is the clear fluid inside the coconut, has natural electrolytes such as potassium, sodium and manganese.

Coconut Water

Oral Electrolytes DRUG

Is be considered a drug that not require medical prescrption and containing water, carbohydrates and electrolytes.

Oral Electrolytes

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Colima: lead
• Carmen Alicia Sanchez Ramirez: collaborator
• Yunue Flores Ruelas: collaborator
• Alexis Adan Lopez Maria: collaborator

Study Sites (1)

Alexis Adan Lopez Maria

Colima, 28040, Mexico

Location

Related Publications (2)

• 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.

  PMID: 12056182 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.

  PMID: 27768399 BACKGROUND

MeSH Terms

Conditions

Dehydration; Motor Activity

Interventions

Electrolytes

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Limitations and Caveats

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.

Results Point of Contact

• Title: Fabian Rojas Larios
• Organization: UColima

frojas@ucol.mx

3121206804

Study Officials

• FABIAN ROJAS LARIOS, PhD

  frojas@ucol.mx

  STUDY DIRECTOR

• Carmen Alcia Sanchez Ramírez, PhD

  carmen_sanchez@ucol.mx

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: September 30, 2022
• Study Start: October 15, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)