Last updated: 11/03/2018 22:23:06

Impact of beverage powder with micronutrients and Brahmi extract on cognitive variables in Indian school children

GSK study ID
202379
See study documents
Clinicaltrials.gov ID
NCT02416245
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

'Between errors' in CANTAB task 'Spatial working memory'

Timeframe: Baseline to 4 months

'Strategy' in CANTAB task 'Spatial working memory'

Timeframe: Baseline to 4 months

Secondary outcomes:

'Total errors (adjusted)' in CANTAB task 'Paired associate learning'

Timeframe: Baseline to 4 months

'Problems solved in minimum moves' in CANTAB task 'Stockings of Cambridge'

Timeframe: Baseline to 4 months

'A Prime' in CANTAB task 'Rapid Visual Information Processing'

Timeframe: Baseline to 4 months

'Median latency' in CANTAB task 'Rapid Visual Information Processing'

Timeframe: Baseline to 4 months

'Total false alarms' in CANTAB task 'Rapid Visual Information Processing'

Timeframe: Baseline to 4 months

CANTAB Score on 'Raven's colored progressive matrices'

Timeframe: Baseline to 4 months

Interventions:
  • Dietary supplement: Beverage powder fortified with micronutrients and Bacopa monnieri extract
  • Other: Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)
    • Enrollment:
    310
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cognition
    Product
    Not applicable
    Collaborators
    Cambridge Cognition
    Study date(s)
    July 2014 to January 2015
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    7 - 12 years
    Accepts healthy volunteers
    Yes
    • 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
    • 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
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Pune, India, 411001
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2015-09-01

    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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