GSK Investigational Site
Karamsad, Gujarat, 388325, India
NCT Number: NCT02177942
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.
Looking for future studies?
Notify Me36 month–65 month
All sexes
Interventional
Not applicable
Karamsad, Gujarat, 388325, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High protein and added Micronutrients at recommended dietary allowance levels
Low protein and no added micronutrients
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.
Time frame: Baseline and 6 months
Weight was measured (single measurement) in standard clothing on weighing scale to the nearest 0.1kilograms(kg).
Time frame: Baseline and 6 months
Height was measured (single measurement) using a portable stadio-meter, with the participant standing bare-foot, to the nearest 0.1centimeters (cm).
Time frame: Baseline and 6 months
BMI for was obtained using the World Health Organization Anthroplus software version 1.0.2.
Time frame: Baseline and 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.
Time frame: Baseline and 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.
Time frame: Baseline and 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
Time frame: Baseline upto 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).
Time frame: Baseline and 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
GlaxoSmithKline
Industry
A Double Blind Randomised Controlled Trial in Pre-school Age Children to Evaluate the Impact of a Nutritional Beverage Powder on Cognitive Performance Measures
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05912556
Brain Function, Brain Health
San Francisco, California, United States
View Trial DetailsNCT07047105
Cognition, Fatigue
Newcastle upon Tyne, United Kingdom
View Trial DetailsNCT07387523
Brain Health Activities, Cognition
Barcelona, Catalonia, Spain
View Trial DetailsNCT06995560
Brain Stimulation, Cognition
Charlestown, Massachusetts, United States
View Trial Details