Growth and DevelopmentNCT02428127
Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children
A study testing Carbohydrate beverage powder, Calorie matched beverage powder and Water in people with Growth and Development, run by GlaxoSmithKline at 1 site in India.
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 Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth and Development
- What is being tested?
- Carbohydrate beverage powder, Calorie matched beverage powder and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2015to 30 May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Growth and Development
- Being tested
- Carbohydrate beverage powder, Calorie matched beverage powder, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate beverage powderDietary supplement
Carbohydrate beverage powder fortified with multiple micronutrients. 20g of study product will be administered orally twice a day
Calorie matched beverage powderDietary supplement
Calorie matched beverage powder with 80% protein.20g of study product will be administered orally twice a day
WaterOther
lukewarm water
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | 20g Carbohydrate powder fortified with multiple micronutrients, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day Receives: 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 Receives: Dietary Supplement: Calorie matched beverage powder |
| Control | Placebo comparator | 200mL lukewarm water given twice a day Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 4h post-baseline
Secondary outcomes (2)
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
Measured: 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).
Measured: Baseline and 4h post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study start1 May 2015
- Primary completion1 May 2015
- Study completion30 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth and DevelopmentStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428127
- Sponsor's protocol ID
- 203093
- Status last verified
- Aug 2018
- First submitted
- 23 Apr 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
http://www.i-scholar.in/index.php/Ijnd/article/view/130266
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children
- ClinicalTrials.gov ID
- NCT02428127
- Acronym / sponsor ID
- 203093
- Conditions
- Growth and Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 30 May 2015 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Dietary Supplement: Carbohydrate beverage powder20g Carbohydrate powder fortified with multiple micronutrients, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day |
| Calorie matched protein powder | Active comparator | Dietary Supplement: Calorie matched beverage powder20g Calorie matched protein powder with 80% protein, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day |
| Control | Placebo comparator | Other: Water200mL lukewarm water given twice a day |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate beverage powderCarbohydrate beverage powder fortified with multiple micronutrients. 20g of study product will be administered orally twice a day | Dietary supplement | Test |
| Calorie matched beverage powderCalorie matched beverage powder with 80% protein.20g of study product will be administered orally twice a day | Dietary supplement | Calorie matched protein powder |
| Waterlukewarm water | Other | Control |
Primary outcome
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
2 secondary outcomes
Change from baseline in Speed fatigue index
Time frame: Baseline and 4h post-baseline
Change from baseline in Mean power output
Time frame: Baseline and 4h post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Backgroundhttp://www.i-scholar.in/index.php/Ijnd/article/view/130266
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate beverage powder, Calorie matched beverage powder and Water in people with Growth and Development, run by GlaxoSmithKline at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Agility fatigue index (time frame: Baseline and 4h post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02428127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.