Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children
NCT ID: NCT02416245
Last Updated: 2015-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
310 participants
INTERVENTIONAL
2014-07-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Test beverage powder
Test beverage powder is fortified with micronutrients and Bacopa monnieri extract. Each sachet contains 32g of treatmemt product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
Beverage powder fortified with micronutrients and Bacopa monnieri extract
Test beverage powder is fortified with micronutrients and Bacopa monnieri extract. Each sachet contains 32g of treatmemt product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
Control beverage powder
Control beverage powder is the non-fortified isocaloric powder i.e. without micronutrients and Bacopa Monnieri extract. Each sachet contains 32g of placebo product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)
Control beverage powder is the non-fortified isocaloric powder i.e. without micronutrients and Bacopa Monnieri extract. Each sachet contains 32g of placebo product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
Interventions
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Beverage powder fortified with micronutrients and Bacopa monnieri extract
Test beverage powder is fortified with micronutrients and Bacopa monnieri extract. Each sachet contains 32g of treatmemt product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)
Control beverage powder is the non-fortified isocaloric powder i.e. without micronutrients and Bacopa Monnieri extract. Each sachet contains 32g of placebo product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
7 Years
12 Years
ALL
Yes
Sponsors
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Cambridge Cognition Ltd
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Pune, , India
Countries
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Other Identifiers
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202379
Identifier Type: -
Identifier Source: org_study_id
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