Trial Outcomes & Findings for Effect of Coconut Water on Hydration Status in Pediatric Population (NCT NCT05562401)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-02-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coconut Water n=17 Participants 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.	Oral Electrolytes n=17 Participants 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.	Total n=34 Participants Total of all reporting groups
Age, Continuous	13.06 years STANDARD_DEVIATION 1.34 • n=17 Participants	13 years STANDARD_DEVIATION 0.79 • n=17 Participants	13.03 years STANDARD_DEVIATION 1.09 • n=34 Participants
Sex: Female, Male Female	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Sex: Female, Male Male	17 Participants n=17 Participants	17 Participants n=17 Participants	34 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weight	53.19 Kilograms STANDARD_DEVIATION 10.85 • n=17 Participants	61.82 Kilograms STANDARD_DEVIATION 12.68 • n=17 Participants	57.50 Kilograms STANDARD_DEVIATION 12.42 • n=34 Participants
Height	162.47 Centimeters STANDARD_DEVIATION 11.81 • n=17 Participants	162.53 Centimeters STANDARD_DEVIATION 10.35 • n=17 Participants	162.5 Centimeters STANDARD_DEVIATION 10.93 • n=34 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Coconut Water n=68 Participants 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.	Oral Electrolytes n=68 Participants 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.
To Determine the Effect of AC vs EO on Hydration Status in Adolescents Who Perform Physical Exercise of Aerobic Competition. Ehuydrated	53 Number participants euhydrated	36 Number participants euhydrated
To Determine the Effect of AC vs EO on Hydration Status in Adolescents Who Perform Physical Exercise of Aerobic Competition. Dehydrated	15 Number participants euhydrated	32 Number participants euhydrated

SECONDARY outcome

Timeframe: 4 weeks

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fabian Rojas Larios

UColima

Phone: 3121206804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place