Clinical TrialID 407
Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children
NCT02416245
Cognition
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 407
- Evidence Id
- 407
- Core Evidence Id
- 407
- Source Clinical Trial Id
- 393
- Herb2 Clinical Trial Id
- HBCT000393
- Nct Id
- NCT02416245
- Title
- Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Cognition
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose:
- Intervention
- DIETARY_SUPPLEMENT: Beverage powder fortified with micronutrients and Bacopa monnieri extract|OTHER: Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Gender
- All
- Age
- Child
- Enrollment
- 310
- Outcome Measure
- 'Between errors' in CANTAB task 'Spatial working memory', 'Spatial working memory' task measures the 'Short term memory' (working memory). In this task, participants search through a series of boxes until they find a blue chip, which they move to the "home" area on right side of screen. They then look for the next blue chip but NOT in same box as before. For each problem, the participant must NOT return to a box they have previously found a blue chip in. Number of boxes is gradually increased from 3 to 8. 'Between errors' is defined as times the participant revisits a box in which a token has previously been found. This is calculated for all trials of four or more tokens only. Scale ranges from 0 to 180 with lower score indicating a better performance., Baseline to 4 months|'Strategy' in CANTAB task 'Spatial working memory', 'Spatial working memory' task measures the 'Short term memory' (working memory). In this task, participants search through a series of boxes until they find a blue chip, which they move to the "home" area on right side of screen. They then look for the next blue chip but NOT in same box as before. Number of boxes is gradually increased from 3 to 8. 'Strategy' is defined as number of distinct boxes used by the participant to begin a new search for a token, within the same problem. Scale ranges from 4 to 28 with a lower score indicating a better performance., Baseline to 4 months
- Sponsor Collaborator
- GlaxoSmithKline|Cambridge Cognition Ltd
- Funded By
- INDUSTRY
- Location
- GSK Investigational Site, Pune, 411001, India
- Other Id
- 202379
- Start Date
- 2014-07
- Primary Completion Date
- 2015-01
- Completion Date
- 2015-03
- First Posted
- 2015-04-14
- Results First Posted
- Last Update Posted
- 2015-07-07
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02416245
- Title Cn
- Title En
- Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children
- Bilingual Status
- semi_complete