A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children

NCT ID: NCT02177942

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 528 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-20
• Study Completion Date: 2015-06-01

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.

Conditions

Cognition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Test beverage powder

30 grams of cereal beverage powder with protein and added micronutrients will be made up to 100 mL drink using luke warm water. Subjects will be administered two doses of the drink (100 mL each) everyday

Group Type: EXPERIMENTAL

Test beverage powder (High Proteins and added micronutrients)

Intervention Type: OTHER

High protein and added Micronutrients at recommended dietary allowance levels

Control beverage powder

30 grams of cereal beverage powder with low protein and no added micronutrients will be made up to 100 mL using luke warm water. Subjects will be administered two doses of the drink (100 mL each) everyday

Group Type: ACTIVE_COMPARATOR

Control beverage powder (Low protein and no added micronutrients)

Intervention Type: OTHER

Low protein and no added micronutrients

Interventions

Test beverage powder (High Proteins and added micronutrients)

High protein and added Micronutrients at recommended dietary allowance levels

Intervention Type: OTHER

Control beverage powder (Low protein and no added micronutrients)

Low protein and no added micronutrients

Intervention Type: OTHER

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.

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 65 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Locations

GSK Investigational Site

Karamsad, Gujarat, India

Countries

India

Other Identifiers

RH01722

Identifier Type: OTHER

Identifier Source: secondary_id

202155

Identifier Type: -

Identifier Source: org_study_id