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

Study Overview

• Status: Completed
• Conditions: Growth and Development
• Intervention / Treatment: Dietary supplement: Carbohydrate beverage powder; Dietary supplement: Calorie matched beverage powder; Other: Water

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Pune, India, 411001
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; 20g Carbohydrate powder fortified with multiple micronutrients, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day	Dietary supplement: Carbohydrate beverage powder; Carbohydrate beverage powder fortified with multiple micronutrients. 20g of study product will be administered orally twice a day
Active Comparator: Calorie matched protein powder; 20g Calorie matched protein powder with 80% protein, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day	Dietary supplement: Calorie matched beverage powder; Calorie matched beverage powder with 80% protein.20g of study product will be administered orally twice a day
Placebo Comparator: Control; 200mL lukewarm water given twice a day	Other: Water; lukewarm water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 30, 2015

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 203093