CognitionNCT02177942
A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children
A study testing Test beverage powder (High Proteins and added micronutrients) in people with Cognition, run by GlaxoSmithKline at 1 site in India.
Trial summary
The effect of supplementation using both protein and multiple micronutrients in preschool age children on cognitive performance and growth is unknown. The study will compare the effect of combination of protein and multiple micronutrients on indicators of cognitive performance and growth in preschool age children. Read more about this study
- Who is it for?
- Ages 36 to 65 monthsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Test beverage powder (High Proteins and added micronutrients)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jun 2014to 1 Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 36 to 65 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Consent: Demonstrates understanding of the study and willingness to participate as evidenced by subject's parents or legally authorised representative's voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Compliance : Understands and is willing, able and likely to comply with all study procedures and restrictions
- General Health : Good general and mental health with, in the opinion of the investigator
- Child with BMI for age between <+1 standard deviation (SD) to > -2SD
Who cannot join
- Children in Care (CiC): A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (lactose, wheat gluten, soy protein) or any of their stated ingredients.
- Child with severe anaemia (Haemoglobin < 7 g/dl) as determined by the non invasive spectrophotometry results.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit
- 5. Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator.
- 6. Recent history (3 months) of serious infections, injuries and/ or surgeries. 7. Children consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week, in the recommended dosage) in the last 1 month prior to screening visit.
- 8. Use of any prescription medications during the study period for more than or equal to two weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Randomised Controlled Trial in Pre-school Age Children to Evaluate the Impact of a Nutritional Beverage Powder on Cognitive Performance Measures
The effect of supplementation using both protein and multiple micronutrients in preschool age children on cognitive performance and growth is unknown. The study will compare the effect of combination of protein and multiple micronutrients on indicators of cognitive performance and growth in preschool age children. Cognitive performance and anthropometric assessments will be measured at baseline and at 6 months.
- Conditions
- Cognition
- Being tested
- Test beverage powder (High Proteins and added micronutrients), Control beverage powder (Low protein and no added micronutrients)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test beverage powder (High Proteins and added micronutrients)Other
High protein and added Micronutrients at recommended dietary allowance levels
Control beverage powder (Low protein and no added micronutrients)Other
Low protein and no added micronutrients
| Study group | Role | What they receive |
|---|---|---|
| Test beverage powder | Experimental | 30 grams of cereal beverage powder with protein and added micronutrients will be made up to 100 mL drink using luke warm water. Subjects will be administered two doses of the drink (100 mL each) everyday Receives: Other: Test beverage powder (High Proteins and added micronutrients) |
| Control beverage powder | Active comparator | 30 grams of cereal beverage powder with low protein and no added micronutrients will be made up to 100 mL using luke warm water. Subjects will be administered two doses of the drink (100 mL each) everyday Receives: Other: Control beverage powder (Low protein and no added micronutrients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Short Term Memory at 6 Months
Short term memory was measured using word order and number recall sub tests of Kaufman Assessment Battery for Children (KABC).In Number Recall, child was asked to repeat series of number in same sequence after making sure that child is paying attention.A score of 0 and 1 given for incorrect and correct response respectively. In Word Order,qualified site staff said series of words and child then pointed pictures of those words in same sequence.Later items (object cards with pictures) included an interference task in which child named colors after hearing the word. Each subtest score was the total of item scores, ranging from 0-31 for word order and 0-22 for number recall. The two subtest scores were standardized for each subject and visit (Z score), and short term memory was calculated as the average of the two standardized values where higher scores reflect better short term memory.
Measured: Baseline and 6 months
Secondary outcomes (8)
Change From Baseline in Weight at 6 Months
Weight was measured (single measurement) in standard clothing on weighing scale to the nearest 0.1kilograms(kg).
Measured: Baseline and 6 months
Change From Baseline in Height at 6 Months
Height was measured (single measurement) using a portable stadio-meter, with the participant standing bare-foot, to the nearest 0.1centimeters (cm).
Measured: Baseline and 6 months
Change From Baseline in Body Mass Index (BMI) at 6 Months
BMI for was obtained using the World Health Organization Anthroplus software version 1.0.2.
Measured: Baseline and 6 months
Change From Baseline in Triceps Skin Fold (TSF) at 6 Months
The TSF was measured in the midline of the posterior aspect of the arm, over the triceps muscle, at a level midway between the lateral projection of the acromion process of the scapula and the inferior margin of the olecranon process of the ulna. The right elbow is flexed at 90°and the midpoint between the acromion and the olecranon process is located and marked at the lateral side of the arm. The skinfold was then measured with the arm hanging loosely while standing. The triceps skinfold was picked up with the left thumb and index finger approximately 1cm proximal to the marked level and the tips calipers were applied to the skin-fold at the marked level. The triceps measurement was done (three measurements) using Holtain calipers to the nearest 0.2 millimeters (mm) and the average value was recorded.
Measured: Baseline and 6 months
Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months
The MUAC (single measurement) was measured midway between the acromion and the olecranon process, while the participant stands with the elbow flexed at 90. The circumference was measured with a fiber glass tape to the nearest 0.1 cm on the right hand.
Measured: Baseline and 6 months
Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months
Using the MUAC measurement and TSF measurement, the arm muscle AMA and AFA were calculated i.e. AMA (cm2) = (MUAC-(π*TSF))2/4 π and AFA (cm2) = (MUAC2/4π) - AMA
Measured: Baseline and 6 months
Number of Ill Days at 6 Months
Number of ill days due to cold, cough and/or associated fever were recorded. The mean number of ill days due was analyzed at 6 months using Analysis of Variance (ANOVA).
Measured: Baseline upto 6 months
Change From Baseline in Problem Solving at 6 Months
Test measured visual construction ability, understanding of spatial relationships and problem solving abilities. The child arranged flat shapes of various sizes and colors (items) to match a model or picture as instructed by the qualified staff. For items 1 to 2 (score 2 for success on first trial and 1 on second trial); items 3 to 10 (Score 1 for success and 0 for failure on first trial). The test continued till 3 consecutive scores of 0. The Raw score was the total of item score.
Score range 0-29. Higher scores reflect better short term memory
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study start20 Jun 2014
- Primary completion1 Jun 2015
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CognitionStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177942
- Sponsor's protocol ID
- 202155
- Other IDs
- RH01722
- Status last verified
- Mar 2019
- First submitted
- 26 Jun 2014
- Last updated
- 1 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomised Controlled Trial in Pre-school Age Children to Evaluate the Impact of a Nutritional Beverage Powder on Cognitive Performance Measures
- ClinicalTrials.gov ID
- NCT02177942
- Acronym / sponsor ID
- 202155
- Conditions
- Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2014 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Posted 1 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of supplementation using both protein and multiple micronutrients in preschool age children on cognitive performance and growth is unknown. The study will compare the effect of combination of protein and multiple micronutrients on indicators of cognitive performance and growth in preschool age children. Cognitive performance and anthropometric assessments will be measured at baseline and at 6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test beverage powder | Experimental | Other: Test beverage powder (High Proteins and added micronutrients)30 grams of cereal beverage powder with protein and added micronutrients will be made up to 100 mL drink using luke warm water. Subjects will be administered two doses of the drink (100 mL each) everyday |
| Control beverage powder | Active comparator | Other: Control beverage powder (Low protein and no added micronutrients)30 grams of cereal beverage powder with low protein and no added micronutrients will be made up to 100 mL using luke warm water. Subjects will be administered two doses of the drink (100 mL each) everyday |
Who may qualify
- Ages
- 36 to 65 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Consent: Demonstrates understanding of the study and willingness to participate as evidenced by subject's parents or legally authorised representative's voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Compliance : Understands and is willing, able and likely to comply with all study procedures and restrictions
- General Health : Good general and mental health with, in the opinion of the investigator
- Child with BMI for age between <+1 standard deviation (SD) to > -2SD
Key exclusion criteria (8 listed)
- Children in Care (CiC): A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (lactose, wheat gluten, soy protein) or any of their stated ingredients.
- Child with severe anaemia (Haemoglobin < 7 g/dl) as determined by the non invasive spectrophotometry results.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit
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 |
|---|---|---|
| Test beverage powder (High Proteins and added micronutrients)High protein and added Micronutrients at recommended dietary allowance levels | Other | Test beverage powder |
| Control beverage powder (Low protein and no added micronutrients)Low protein and no added micronutrients | Other | Control beverage powder |
Primary outcome
Change From Baseline in Short Term Memory at 6 Months
Time frame: Baseline and 6 months
Short term memory was measured using word order and number recall sub tests of Kaufman Assessment Battery for Children (KABC).In Number Recall, child was asked to repeat series of number in same sequence after making sure that child is paying attention.A score of 0 and 1 given for incorrect and correct response respectively. In Word Order,qualified site staff said series of words and child then pointed pictures of those words in same sequence.Later items (object cards with pictures) included an interference task in which child named colors after hearing the word. Each subtest score was the total of item scores, ranging from 0-31 for word order and 0-22 for number recall. The two subtest scores were standardized for each subject and visit (Z score), and short term memory was calculated as the average of the two standardized values where higher scores reflect better short term memory.
8 secondary outcomes
Change From Baseline in Weight at 6 Months
Time frame: Baseline and 6 months
Change From Baseline in Height at 6 Months
Time frame: Baseline and 6 months
Change From Baseline in Body Mass Index (BMI) at 6 Months
Time frame: Baseline and 6 months
Change From Baseline in Triceps Skin Fold (TSF) at 6 Months
Time frame: Baseline and 6 months
Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months
Time frame: Baseline and 6 months
Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months
Time frame: Baseline and 6 months
Number of Ill Days at 6 Months
Time frame: Baseline upto 6 months
Change From Baseline in Problem Solving at 6 Months
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test beverage powder (High Proteins and added micronutrients) in people with Cognition, 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 8 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 1 Apr 2019. 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. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Short Term Memory at 6 Months (time frame: Baseline and 6 months). 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 1 Apr 2019.