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

Growth and Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428127
• Other study ID #: 203093
• Status: Completed
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: May 30, 2015

Study information

• Verified date: August 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Growth and Development

Intervention

Dietary Supplement:
• Carbohydrate beverage powder
Carbohydrate beverage powder fortified with multiple micronutrients. 20g of study product will be administered orally twice a day
• Calorie matched beverage powder
Calorie matched beverage powder with 80% protein.20g of study product will be administered orally twice a day

Other:
• Water
lukewarm water

Locations

Country	Name	City	State
India	GSK Investigational Site	Pune

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

References & Publications (1)

http://www.i-scholar.in/index.php/Ijnd/article/view/130266

Outcome

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 time÷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 time÷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