CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Oral Electrolytes +1 moredrug
Likely dose
Not stated in record
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Search/NCT05562401
NCT05562401Phase 4Completed

Effect of Coconut Water Compared to Oral Electrolytes on Hydration Status in Adolescents Who Perform Physical Exercise: Randomized Clinical Trial, Double-blind

Universidad de Colima·interventional·Posted Sep 30, 2022·Updated Feb 21, 2025

In Brief

A Phase 4 clinical trial evaluating Coconut Water and Oral Electrolytes for Sports Nutrition. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedSep 30, 2022
Enrollment StartOct 15, 2021
Primary CompletionMay 30, 2022
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.8 years ago

Interventions

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.