Trial Outcomes & Findings for A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children (NCT NCT02177942)

NCT ID: NCT02177942

Last Updated: 2019-04-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 528 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2019-04-01

Participant Flow

Participants were recruited at one center in India.

A total of 656 participants were screened out of which 528 were randomized to study treatments. 363 participants completed the study. Of the 165 randomized participants not completing the study, 152 withdrew consent, 10 participants violated the protocol, 2 participants were lost to follow up and 1 withdrew due to adverse event.

Participant milestones

Measure	Test 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mililiters (mL) drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Overall Study STARTED	262	266
Overall Study COMPLETED	185	178
Overall Study NOT COMPLETED	77	88

Reasons for withdrawal

Measure	Test 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mililiters (mL) drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	4	6
Overall Study Withdrawal by Subject	71	81

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Total n=363 Participants Total of all reporting groups
Age, Continuous	4.21 Years STANDARD_DEVIATION 0.607 • n=5 Participants	4.24 Years STANDARD_DEVIATION 0.646 • n=7 Participants	4.22 Years STANDARD_DEVIATION 0.626 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	66 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	112 Participants n=7 Participants	214 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

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.

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Change From Baseline in Short Term Memory at 6 Months	-0.04 Score on a scale Standard Deviation 0.926	-0.01 Score on a scale Standard Deviation 0.856

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

Weight was measured (single measurement) in standard clothing on weighing scale to the nearest 0.1kilograms(kg).

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Change From Baseline in Weight at 6 Months	0.15 kg Standard Deviation 0.436	0.14 kg Standard Deviation 0.454

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

Height was measured (single measurement) using a portable stadio-meter, with the participant standing bare-foot, to the nearest 0.1centimeters (cm).

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Change From Baseline in Height at 6 Months	0.23 cm Standard Deviation 0.442	0.20 cm Standard Deviation 0.368

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

BMI for was obtained using the World Health Organization Anthroplus software version 1.0.2.

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Change From Baseline in Body Mass Index (BMI) at 6 Months	0.00 kg/m^2 Standard Deviation 0.584	0.02 kg/m^2 Standard Deviation 0.634

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

The TSF was measured in the midline of the posterior aspect of the arm, over the triceps muscle, at a level midway between the lateral projection of the acromion process of the scapula and the inferior margin of the olecranon process of the ulna. The right elbow is flexed at 90°and the midpoint between the acromion and the olecranon process is located and marked at the lateral side of the arm. The skinfold was then measured with the arm hanging loosely while standing. The triceps skinfold was picked up with the left thumb and index finger approximately 1cm proximal to the marked level and the tips calipers were applied to the skin-fold at the marked level. The triceps measurement was done (three measurements) using Holtain calipers to the nearest 0.2 millimeters (mm) and the average value was recorded.

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Change From Baseline in Triceps Skin Fold (TSF) at 6 Months	-0.33 mm Standard Deviation 1.810	-0.33 mm Standard Deviation 2.062

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

The MUAC (single measurement) was measured midway between the acromion and the olecranon process, while the participant stands with the elbow flexed at 90. The circumference was measured with a fiber glass tape to the nearest 0.1 cm on the right hand.

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months	0.55 cm Standard Deviation 1.131	0.57 cm Standard Deviation 1.016

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

Using the MUAC measurement and TSF measurement, the arm muscle AMA and AFA were calculated i.e. AMA (cm2) = (MUAC-(π*TSF))2/4 π and AFA (cm2) = (MUAC2/4π) - AMA

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months Change from Baseline at 6 months (AMA)	1.34 Centimeter square Cm^2 Standard Deviation 2.770	1.39 Centimeter square Cm^2 Standard Deviation 2.509
Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months Change from Baseline at 6 months (AFA)	-0.01 Centimeter square Cm^2 Standard Deviation 1.146	0.00 Centimeter square Cm^2 Standard Deviation 1.330

SECONDARY outcome

Timeframe: Baseline upto 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

Number of ill days due to cold, cough and/or associated fever were recorded. The mean number of ill days due was analyzed at 6 months using Analysis of Variance (ANOVA).

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Number of Ill Days at 6 Months	5.94 Number of days Standard Deviation 3.130	7.45 Number of days Standard Deviation 8.976

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.

Test measured visual construction ability, understanding of spatial relationships and problem solving abilities. The child arranged flat shapes of various sizes and colors (items) to match a model or picture as instructed by the qualified staff. For items 1 to 2 (score 2 for success on first trial and 1 on second trial); items 3 to 10 (Score 1 for success and 0 for failure on first trial). The test continued till 3 consecutive scores of 0. The Raw score was the total of item score.

Score range 0-29. Higher scores reflect better short term memory

Outcome measures

Measure	Test n=185 Participants 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=178 Participants 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Change From Baseline in Problem Solving at 6 Months	2.86 Score on a scale Standard Deviation 2.924	3.03 Score on a scale Standard Deviation 2.813

Adverse Events

Test

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Control

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Test n=259 participants at risk 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=265 participants at risk 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Nervous system disorders CONVULSION	0.00% 0/259 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.38% 1/265 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Nervous system disorders STATUS EPILAPTICUS	0.00% 0/259 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.38% 1/265 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Infections and infestations ACUTE GASTRO ENTERITIS	0.00% 0/259 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.38% 1/265 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).

Other adverse events

Measure	Test n=259 participants at risk 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.	Control n=265 participants at risk 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
Infections and infestations NASOPHARYNGITIS	3.5% 9/259 • Number of events 9 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	3.8% 10/265 • Number of events 10 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	2.7% 7/259 • Number of events 7 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	3.8% 10/265 • Number of events 10 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Infections and infestations PYODERMA	0.39% 1/259 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.00% 0/265 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Infections and infestations VARICELLA	0.39% 1/259 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.38% 1/265 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Infections and infestations GASTROENTERITIS	0.00% 0/259 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	1.1% 3/265 • Number of events 3 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Infections and infestations IMPETIGO	0.00% 0/259 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.38% 1/265 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Infections and infestations TYPHOID FEVER	0.00% 0/259 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.38% 1/265 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Gastrointestinal disorders VOMITING	2.3% 6/259 • Number of events 6 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	2.3% 6/265 • Number of events 6 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Gastrointestinal disorders DIARRHOEA	1.2% 3/259 • Number of events 3 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	1.1% 3/265 • Number of events 3 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Infections and infestations NAUSEA	0.00% 0/259 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.38% 1/265 • Number of events 1 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
General disorders PYREXIA	1.2% 3/259 • Number of events 3 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	3.0% 8/265 • Number of events 8 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
Respiratory, thoracic and mediastinal disorders COUGH	1.2% 3/259 • Number of events 3 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).	0.75% 2/265 • Number of events 2 Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER