NCT02428127

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2015

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

April 23, 2015

Last Update Submit

August 29, 2018

Conditions

Growth and Development

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline in Speed fatigue index

    Baseline and 4h post-baseline

  • Change from baseline in Mean power output

    Baseline and 4h post-baseline

Study Arms (3)

Test

EXPERIMENTAL

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

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

Dietary Supplement: Calorie matched beverage powder

Control

PLACEBO COMPARATOR

200mL lukewarm water given twice a day

Other: Water

Interventions

Carbohydrate beverage powderDIETARY_SUPPLEMENT

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

Test
Calorie matched beverage powderDIETARY_SUPPLEMENT

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

Calorie matched protein powder
WaterOTHER

lukewarm water

Control

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Pune, 411001, India

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 30, 2015

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

IN(1)