N/A
N=528
A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children
Cognition
Bottom Line
View on ClinicalTrials.gov: NCT02177942 ↗Enrolled (actual)
528
Serious AEs
0.6%
Results posted
Apr 2019
Primary outcome: Primary: Change From Baseline in Short Term Memory at 6 Months — -0.04; -0.01 Score on a scale — p=0.6931
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test beverage powder (High Proteins and added micronutrients) (Other); Control beverage powder (Low protein and no added micronutrients) (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Short Term Memory at 6 Months |
-0.04; -0.01 | 0.6931 |
| SECONDARY Change From Baseline in Weight at 6 Months |
0.15; 0.14 | — |
| SECONDARY Change From Baseline in Height at 6 Months |
0.23; 0.20 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at 6 Months |
0.00; 0.02 | — |
| SECONDARY Change From Baseline in Triceps Skin Fold (TSF) at 6 Months |
-0.33; -0.33 | — |
| SECONDARY Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months |
0.55; 0.57 | — |
| SECONDARY Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months |
1.34; 1.39; -0.01; 0.00 | — |
| SECONDARY Number of Ill Days at 6 Months |
5.94; 7.45 | — |
| SECONDARY Change From Baseline in Problem Solving at 6 Months |
2.86; 3.03 | — |
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
- 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 -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. 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.
- Use of any prescription medications during the study period for more than or equal to two weeks.
Data sourced from ClinicalTrials.gov (NCT02177942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.