Last updated: 07/18/2020 12:13:33
A clinical trial to study the impact of a nutritional beverage on tests of memory in healthy preschool age children
GSK study ID
202155
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from baseline in short term memory at 6 months
Timeframe: Baseline and 6 months
Secondary outcomes:
Change from baseline in weight at 6 months
Timeframe: Baseline and 6 months
Change from baseline in height at 6 months
Timeframe: Baseline and 6 months
Change from baseline in body mass index (BMI) at 6 months
Timeframe: Baseline and 6 months
Change from baseline in triceps skin fold (TSF) at 6 months
Timeframe: Baseline and 6 months
Change from baseline in mid upper arm circumference (MUAC) at 6 months
Timeframe: Baseline and 6 months
Change from baseline in arm muscle area (AMA) and arm fat area (AFA) at 6 months
Timeframe: Baseline and 6 months
Number of ill days at 6 months
Timeframe: Baseline upto 6 months
Change from baseline in problem solving at 6 months
Timeframe: Baseline and 6 months
Interventions:
Enrollment:
528
Primary completion date:
2015-01-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cognition
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2014 to June 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
36 - 65 months
Accepts healthy volunteers
Yes
- 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
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-01-06
Actual study completion date
2015-01-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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