A Double Blind Randomised Controlled Trial in Pre-school Age Children to Evaluate the Impact of a Nutritional Beverage Powder on Cognitive Performance Measures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cognition
- Sponsor
- GlaxoSmithKline
- Enrollment
- 528
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Short Term Memory at 6 Months
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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. Cognitive performance and anthropometric assessments will be measured at baseline and at 6 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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.
- •Recent history (3 months) of serious infections, injuries and/ or surgeries.
- •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.
- •Use of any prescription medications during the study period for more than or equal to two weeks.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change From Baseline in Height at 6 Months(Baseline and 6 months)
- Change From Baseline in Body Mass Index (BMI) at 6 Months(Baseline and 6 months)
- Number of Ill Days at 6 Months(Baseline upto 6 months)
- Change From Baseline in Weight at 6 Months(Baseline and 6 months)
- Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months(Baseline and 6 months)
- Change From Baseline in Triceps Skin Fold (TSF) at 6 Months(Baseline and 6 months)
- Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months(Baseline and 6 months)
- Change From Baseline in Problem Solving at 6 Months(Baseline and 6 months)