Clinical trial NCT02416245: Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children
Official title: Impact of a Beverage Powder Fortified With Multiple Micronutrients (MMN) and Bacopa Monnieri Extract (EBM) on Cognitive Variables in Indian School Children (7-12yrs; Inclusive) After 4 Months of Intervention: a Double Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Cambridge Cognition Ltd
First posted: 2015-04-14
Enrollment: 310
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the current study is to investigate the beneficial impact of 4 month consumption of a beverage powder fortified with Brahmi (Bacopa monnieri) extract and multiple vitamins and minerals on short term memory as assessed using standardised cognitive test battery.

Detailed description: Bacopa monnieri (Brahmi) from Scrophulariaceae family has been traditionally used in India as 'memory tonic'. Brahmi's use as a cognitive enhancer has led to recent research to investigate a broad spectrum of cognitive domains. Additionally, micronutrient deficiency in children can impair cognitive functions, and micronutrient supplementation can help reduce/prevent deficiencies in those at risk. Several studies have been conducted so far which establish the cognition enahncing abilities of Brahmi, with no major side effects. The aim of the current study is to investigate the beneficial impact of 4 month consumption of a beverage powder fortified with Brahmi extract and multiple vitamins and minerals on short term memory as assessed using standardised cognitive test battery.

Eligibility criteria: Inclusion Criteria:

* Z-score of Body Mass Index (BMI) for age of \>-2 to \<-1
* Participant and participant's parents/legally authorized representatives (LAR) understand and are willing, able and likely to comply with all the study procedures
* Participant is in good general health; has no condition that could affect the safety of participant

Exclusion Criteria:

* Child in care: A child who is placed under the control/protection of an agency/organization/institution by the court/government
* Allergy/Intolerance/Hypersensitivity any study ingredient
* Severe anaemia (Hb\<8g/dL); Attention Deficit Hyperactivity Disorder; Reading dyslexia or behavioral disorders
* Health condition that could affect food metabolism; any physical or psychiatric illness that could lead to non-completion of study
* Concurrent use of other health food drinks/supplements, within 1 month prior to study start
* Sibling participation in study

Primary outcomes:
measure: 'Between errors' in CANTAB task 'Spatial working memory'
timeFrame: Baseline to 4 months
measure: 'Strategy' in CANTAB task 'Spatial working memory'
timeFrame: Baseline to 4 months
Secondary outcomes:
measure: 'Total errors (adjusted)' in CANTAB task 'Paired associate learning'
timeFrame: Baseline to 4 months
measure: 'Problems solved in minimum moves' in CANTAB task 'Stockings of Cambridge'
timeFrame: Baseline to 4 months
measure: 'A Prime' in CANTAB task 'Rapid Visual Information Processing'
timeFrame: Baseline to 4 months
measure: 'Median latency' in CANTAB task 'Rapid Visual Information Processing'
timeFrame: Baseline to 4 months
measure: 'Total false alarms' in CANTAB task 'Rapid Visual Information Processing'
timeFrame: Baseline to 4 months
measure: CANTAB Score on 'Raven's colored progressive matrices'
timeFrame: Baseline to 4 months
Other outcomes:
Locations:
city: Pune
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: