Last updated: 11/03/2018 22:23:06
Impact of beverage powder with micronutrients and Brahmi extract on cognitive variables in Indian school children
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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