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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03497858
Other study ID # 111166
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 6, 2018
Last updated April 6, 2018
Start date April 15, 2018
Est. completion date October 30, 2018

Study information

Verified date April 2018
Source Western University, Canada
Contact Peter Lemon, PhD
Phone 519-661-2111
Email plemon@uwo.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess whether there is a performance enhancing effect associated with hydrating with coconut water. There have been only two studies in the past that have examined this phenomenon, however these studies have limitations due to their design parameters. Kalman et al. (2012) ".... while treadmill time to exhaustion is routinely used in laboratory studies, the use of a time trial test as the measure of exercise performance may be more appropriate." While Peart et al. (2016) stated: "limitations to the exercise protocol employed here may have contributed to the absence of a performance improvement with coconut water."


Description:

Purpose The purpose of the study is to determine whether hydrating with coconut water during a game-simulated, basketball-specific training session can enhance performance. It is hypothesized that coconut water will provide an ergogenic effect for basketball players.

Sample The sample will include 20 varsity basketball players, male and female, ranging in age from 18-35 who volunteer to participate in the study. This sample size is justified assuming a standard deviation of 1.5 based on previous studies and using a power of 80% with the statistical significance of 0.05 the resulting n would be 2(1.5)^2*(0.84+1.96)^2/5=7 (Kadam, P., & Bhalerao, S. (2010). Sample size calculation. International journal of Ayurveda research, 1(1), 55). To account for dropouts, 10 participants will be recruited for each group. Participants will be required to have no history of kidney problems. All individuals must give written informed consent in order to participate in the study. Exclusion criteria include not being a varsity basketball player, being younger than 18 or older than 35, or having a history of kidney problems.

Procedure Inclusion/exclusion criteria will be explicitly stated throughout the recruitment process. Potential participants will be recruited through first contacting the Men's and Women's Head Basketball Coaches of Western University and obtaining approval of collaboration from the team. Players will then be in direct contact with Reed Zehr to gain information of study. After given the study details, individuals will be given up to 3 days to determine if they want to participate and give their informed consent. See attached form in the consent section of the ethics application.

Measurement: All players will perform two sessions of a 10 minute BSST (Basketball Specific Skills Test) which will represent the 1st and 2nd quarter respectively. Field Goal Attempts (FGA) (#), Field Goals Made (FGM) (#), Field Goal Percentage (FGP) (%) will be measured from the free-throw line, mid-range and three point distances during the BSST. A dribbling drill will be used as well and number of dribbles (#) will be measured. All players will then perform two sessions of a 10 minute BEST (Basketball Exercise Simulation Test) test which will represent the 3rd and 4th quarter of a basketball game. Total distance covered (m), Mean circuit completion time (s), mean sprint time (s), and total sprint decrement (%) will be measured during the BEST.

Protocol: On test days, participants will report to he Gym at 0600 h after a 12 h overnight fast and having abstained from any strenuous exercise following the evening meal. At 0615 h, participants will consume a standardized breakfast (toast and jam) and the first beverage of 750mL. At 0730 h, participants will be told to consume the second beverage of 250mL. At 0745 h, the participants will undergo the first 10 min quarter of the BSST. At 0755 h, the participants rest during a 2 min break (1st intermission) and consume the third beverage of 250mL. At 0757 h, the participants will undergo the second session of the BSST. At 0807 h, the participants receive a 15 min break (half-time) and consume the fourth beverage of 500mL. At 0822 h, the participants will undergo the first BEST. At 0832 h, the participants receive a 2 min break (2nd intermission) and consume the final beverage of 250mL. At 0834 h, the participants undergo the second BEST. At 0844, the exercise bout will be completed. Participants will complete this protocol for each of the three experimental conditions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date October 30, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Must be between 18-35 years old

- Must be a Canadian Varsity Basketball Player

Exclusion Criteria:

- Younger than 18 or older than 35

- Not a Canadian Varsity Basketball Player

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Coconut Water
participants will consume coconut water and complete a simulated basketball game
Placebo - water
participants will consume Placebo - water and complete a simulated basketball game
Sports drink
participants will consume a sports drink and complete a simulated basketball game

Locations

Country Name City State
Canada Exercise Nutrition Laboratory (Western University) London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Kalman DS, Feldman S, Krieger DR, Bloomer RJ. Comparison of coconut water and a carbohydrate-electrolyte sport drink on measures of hydration and physical performance in exercise-trained men. J Int Soc Sports Nutr. 2012 Jan 18;9(1):1. doi: 10.1186/1550-27 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Field Goal Percentage shots made / shots attempted X 100 16 mins
Primary Dribbles Performed number bounces 5 minutes
Primary Total Sprint Decrement 100 x (total sprint time / ideal sprint time) - 100 20 mins
Primary Distance run meteres run 20 mins
Secondary Rating of Perceived Exertion Subjective rating from 6-20, 6 being easy and 20 being very, very hard 2 mins
See also
  Status Clinical Trial Phase
Withdrawn NCT04737629 - Understanding the Effects of Water-related Appetite Expectancies on Caloric Intake in College Students N/A
Not yet recruiting NCT06020027 - Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families N/A