Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children

NCT02416245 | Completed DMC

• 1 other identifier: 202379
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition

Outcome Measures

Primary Outcomes (2)

• '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

Secondary Outcomes (6)

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

  Baseline to 4 months

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

  Baseline to 4 months

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

  Baseline to 4 months

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

  Baseline to 4 months

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

  Baseline to 4 months

Study Arms (2)

Test beverage powder

EXPERIMENTAL

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

Dietary Supplement: Beverage powder fortified with micronutrients and Bacopa monnieri extract

Control beverage powder

PLACEBO COMPARATOR

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

Other: Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)

Interventions

Beverage powder fortified with micronutrients and Bacopa monnieri extract DIETARY_SUPPLEMENT

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

Test beverage powder

Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract) OTHER

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

Control beverage powder

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Cambridge Cognition Ltd: collaborator

Study Sites (1)

GSK Investigational Site

Pune, 411001, India

Location

MeSH Terms

Interventions

Micronutrients

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 14, 2015
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 7, 2015

Record last verified: 2015-06

Locations

IN (1)