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OpenTrials
Completed

NCT Number: NCT02428127

Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children

The purpose of this study is to investigate the impact of a beverage containing carbohydrate powder fortified with micronutrients on agility, speed, and power in school going children

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Key information

Conditions

Growth and Development

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Pune, 411001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent by participant's parents or legally accepted representative
  • Good general health
  • Non anemic children (Hb≥12 g/dl)
  • Academy/development level athlete (at least 3 activity sessions per week, for a minimum of 2 hours of activity in each session e.g. hockey, football, team sports)

Exclusion criteria

  • Child in care
  • Allergy/Intolerance to study materials
  • History of cardiovascular disorder, respiratory diseases, diabetes mellitus, serious infection/injuries/surgeries (within past 3 months)
  • Participation in any nutritional study in past 1 year
  • Substance abuse
  • Children on any kind of medication in past 1 month of screening

Treatment and study plan

Carbohydrate beverage powder

Dietary Supplement

Carbohydrate beverage powder fortified with multiple micronutrients. 20g of study product will be administered orally twice a day

Calorie matched beverage powder

Dietary Supplement

Calorie matched beverage powder with 80% protein.20g of study product will be administered orally twice a day

Water

Other

lukewarm water

Primary outcomes

  1. Change from baseline in Agility fatigue index

    Time frame: Baseline and 4h post-baseline

    Agility fatigue index (FI) will be calculated from Repeat Agility Performance Test, using 'Brower equipment'. This assessment includes a 24 meter agility run, repeated on 6 occasions, with every sprint and recovery interval lasting for 65 seconds (eg. if the first agility effort takes the participant 5 seconds, they will have 55 seconds to return to start line for a 5 seconds countdown before their second agility effort). Agility FI=[100X(total agility time÷ideal agility time)]-100. Here, ideal agility time is the best agility time for each participant multiplied by number of repetitions

Secondary outcomes

  1. Change from baseline in Speed fatigue index

    Time frame: Baseline and 4h post-baseline

    Speed fatigue index (FI) will be calculated from Repeat Sprint Performance Test, using 'Brower equipment'. This assessment includes a 30 meter sprint, repeated on 6 occasions, with every sprint and recovery interval lasting for 65 seconds (eg. if the first sprint takes the participant 5 seconds, they will have 55 seconds to return to start line for a 5 second countdown before their second sprint). Speed FI=[100X(total speed time÷ideal speed time)]-100. Here, ideal speed time is the best speed time for each participant multiplied by number of repetitions

  2. Change from baseline in Mean power output

    Time frame: Baseline and 4h post-baseline

    Mean power output (MPO) will be calculated from Wingate Anaerobic Test, using 'Cycle ergometer'. The participant is allowed to pedal at a constant pace, without resistance and then with additional weights (resistance). This is repeated on three occasions. Overall MPO=(sum of MPO from 3 repetitions at baseline)-(sum of MPO from 3 repetitions at post treatment).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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