ConcentrationNCT01355601
Effect of Carbohydrates From Nutritional Beverages in Children
A study testing Nutritional Beverage in people with Concentration and Learning, run by Mead Johnson Nutrition at 1 site in United States.
Trial summary
This clinical trial will determine the effect of varying types of carbohydrates on children's concentration. Read more about this study
- Who is it for?
- Ages 33 to 39 monthsHealthy volunteers can take part
- Conditions the study is for
- Concentration, Learning
- What is being tested?
- Nutritional Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2014
- 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 33 to 39 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 33 months - 39 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial will determine the effect of varying types of carbohydrates on children's concentration.
- Conditions
- Concentration, Learning
- Being tested
- Nutritional Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional BeverageOther
Nutritional Beverage with varying types and levels of carbohydrates
Nutritional BeverageOther
Nutritional beverage with varying types and levels of carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Control A | Experimental | Nutritional beverage containing varying types and levels of carbohydrates Receives: Other: Nutritional Beverage |
| Group 2 - Experimental A | Experimental | Nutritional Beverage with varying types and levels of carbohydrates Receives: Other: Nutritional Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration
Children's ability to concentrate
Secondary outcomes (3)
Attention
Measures of Attention and Distractibility
Short-Term Memory
Sentence Repetition
Rule Learning
Rule Learning Tasks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Terminated due to slow recruitment. 41 of 50 participants had enrolled at time of termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcentrationStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355601
- Sponsor's protocol ID
- 6011
- Status last verified
- Feb 2014
- First submitted
- 16 May 2011
- Last updated
- 27 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carbohydrates From Nutritional Beverages in Children
- ClinicalTrials.gov ID
- NCT01355601
- Acronym / sponsor ID
- 6011
- Conditions
- Concentration, Learning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow recruitment. 41 of 50 participants had enrolled at time of termination.
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 May 2011 (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.
This clinical trial will determine the effect of varying types of carbohydrates on children's concentration.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Control A | Experimental | Other: Nutritional BeverageNutritional beverage containing varying types and levels of carbohydrates |
| Group 2 - Experimental A | Experimental | Other: Nutritional BeverageNutritional Beverage with varying types and levels of carbohydrates |
Who may qualify
- Ages
- 33 to 39 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 33 months - 39 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nutritional BeverageNutritional Beverage with varying types and levels of carbohydrates | Other | Group 1 - Control A |
| Nutritional BeverageNutritional beverage with varying types and levels of carbohydrates | Other | Group 2 - Experimental A |
Primary outcome
Concentration
Children's ability to concentrate
3 secondary outcomes
Attention
Short-Term Memory
Rule Learning
Results and safety
The study was stopped early (reason given: Terminated due to slow recruitment. 41 of 50 participants had enrolled at time of termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Beverage in people with Concentration and Learning, run by Mead Johnson Nutrition at 1 site in United States.
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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 27 Feb 2014. 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 United States. 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. 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 was stopped early (reason given: Terminated due to slow recruitment. 41 of 50 participants had enrolled at time of termination.). Results are not available in the source record.
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?
Concentration. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2014.