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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Bacopa monnieri (Brahmi) from Scrophulariaceae family has been traditionally used in India as 'memory tonic'. Brahmi's use as a cognitive enhancer has led to recent research to investigate a broad spectrum of cognitive domains. Additionally, micronutrient deficiency in children can impair cognitive functions, and micronutrient supplementation can help reduce/prevent deficiencies in those at risk. Several studies have been conducted so far which establish the cognition enahncing abilities of Brahmi, with no major side effects. The aim of the current study is to investigate the beneficial impact of 4 month consumption of a beverage powder fortified with Brahmi extract and multiple vitamins and minerals on short term memory as assessed using standardised cognitive test battery.

Conditions

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Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

Beverage powder fortified with micronutrients and Bacopa monnieri extract

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cambridge Cognition Ltd

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Pune, , India

Site Status

Countries

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India

Other Identifiers

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202379

Identifier Type: -

Identifier Source: org_study_id

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