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

NCT02177942 | Completed Results

• 2 other identifiers: 202155RH01722
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Short Term Memory at 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.

  Baseline and 6 months

Secondary Outcomes (8)

• Change From Baseline in Weight at 6 Months

  Baseline and 6 months

• 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

• 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

Study Arms (2)

Test beverage powder

EXPERIMENTAL

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

Other: Test beverage powder (High Proteins and added micronutrients)

Control beverage powder

ACTIVE COMPARATOR

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

Other: Control beverage powder (Low protein and no added micronutrients)

Interventions

Test beverage powder (High Proteins and added micronutrients) OTHER

High protein and added Micronutrients at recommended dietary allowance levels

Test beverage powder

Control beverage powder (Low protein and no added micronutrients) OTHER

Low protein and no added micronutrients

Control beverage powder

Eligibility Criteria

• Age: 36 Months - 65 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Karamsad, Gujarat, 388325, India

Location

MeSH Terms

Interventions

Diet, Protein-Restricted

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 30, 2014
• Study Start: June 20, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 1, 2019
• Results First Posted: April 1, 2019

Record last verified: 2019-03

Locations

IN (1)