Clinical trial NCT02177942: A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-06-30
Enrollment: 528
Sex: ALL
Minimum age (years): 36
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Compliance : Understands and is willing, able and likely to comply with all study procedures and restrictions
3. General Health : Good general and mental health with, in the opinion of the investigator
4. Child with BMI for age between \<+1 standard deviation (SD) to \> -2SD

Exclusion Criteria:

1. 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.
2. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (lactose, wheat gluten, soy protein) or any of their stated ingredients.
3. Child with severe anaemia (Haemoglobin \< 7 g/dl) as determined by the non invasive spectrophotometry results.
4. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
5. 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.

Primary outcomes:
measure: Change From Baseline in Short Term Memory at 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in Weight at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Height at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Body Mass Index (BMI) at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Triceps Skin Fold (TSF) at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months
timeFrame: Baseline and 6 months
measure: Number of Ill Days at 6 Months
timeFrame: Baseline upto 6 months
measure: Change From Baseline in Problem Solving at 6 Months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Karamsad
country: India
facility: GSK Investigational Site
state: Gujarat
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: