Growth and Development Clinical Trial
Official title:
Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children
NCT number | NCT02428127 |
Other study ID # | 203093 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2015 |
Est. completion date | May 30, 2015 |
Verified date | August 2018 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | May 30, 2015 |
Est. primary completion date | May 1, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 15 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
India | GSK Investigational Site | Pune |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
India,
http://www.i-scholar.in/index.php/Ijnd/article/view/130266
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Agility fatigue index | 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 timeĆ·ideal agility time)]-100. Here, ideal agility time is the best agility time for each participant multiplied by number of repetitions | Baseline and 4h post-baseline | |
Secondary | Change from baseline in Speed fatigue index | 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 timeĆ·ideal speed time)]-100. Here, ideal speed time is the best speed time for each participant multiplied by number of repetitions | Baseline and 4h post-baseline | |
Secondary | Change from baseline in Mean power output | 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). | Baseline and 4h post-baseline |
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