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Clinical Trials/NCT02428127
NCT02428127CompletedNot Applicable

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

GlaxoSmithKline2 sites in 1 country30 target enrollmentStarted: May 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Change from baseline in Agility fatigue index

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Investigator)

Eligibility Criteria

Ages
12 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Test

Experimental

20g Carbohydrate powder fortified with multiple micronutrients, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day

Intervention: Carbohydrate beverage powder (Dietary Supplement)

Calorie matched protein powder

Active Comparator

20g Calorie matched protein powder with 80% protein, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day

Intervention: Calorie matched beverage powder (Dietary Supplement)

Control

Placebo Comparator

200mL lukewarm water given twice a day

Intervention: Water (Other)

Outcomes

Primary Outcomes

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

  • Change from baseline in Mean power output(Baseline and 4h post-baseline)
  • Change from baseline in Speed fatigue index(Baseline and 4h post-baseline)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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