CognitionNCT02416245
Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children
A study testing Beverage powder fortified with micronutrients and Bacopa monnieri extract in people with Cognition, run by GlaxoSmithKline at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Beverage powder fortified with micronutrients and Bacopa monnieri extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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
- Cognition
- Being tested
- Beverage powder fortified with micronutrients and Bacopa monnieri extract, Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage powder fortified with micronutrients and Bacopa monnieri extractDietary 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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
'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.
Measured: 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.
Measured: Baseline to 4 months
Secondary outcomes (6)
'Total errors (adjusted)' in CANTAB task 'Paired associate learning'
'Paired associate learning' task measures the 'Episodic memory'. In this task, boxes are displayed on the screen and open up in a randomised order to reveal a number of patterns. The participant must remember which pattern is in which box. The number of patterns gradually increases up to a number of eight but the participant has multiple attempts to remember each location. 'Total errors (adjusted)' is defined as the number of times the participant choose the incorrect box for a stimulus on assessment problems, plus an adjustment for the estimated number of errors they would have made on any problems, attempts and recalls they did not reach. Scale ranges from 0 to 88 with a lower score indicating a better performance.
Measured: Baseline to 4 months
'Problems solved in minimum moves' in CANTAB task 'Stockings of Cambridge'
This task measures 'Executive functioning'. The participant is shown two displays containing 3 colored balls. The displays are presented in such a way that they can easily be perceived as stacks of colored balls held in stockings or socks suspended from a beam. This arrangement makes the 3-D concepts involved apparent to the participant, and fits with the verbal instructions. The participant must use the balls in the lower display to copy the pattern shown in the upper display. The balls may be moved one at a time by touching the required ball, then touching the position to which it should be moved. The time taken to complete the pattern and the number of moves required are taken as measures of the subject's planning ability. 'Problems solved in minimum moves' is defined as the number of occasions upon which the participant has successfully completed a test problem in the minimum possible number of moves. Scale ranges from 0 to 14 with a higher score indicating a better performance.
Measured: Baseline to 4 months
'A Prime' in CANTAB task 'Rapid Visual Information Processing'
'Rapid Visual Information Processing' task measures 'Sustained attention'. In this task, the screen will display a box which randomly flashes the numbers 2-9. The participant must press the button on the screen to respond when they see a target sequence of 3-5-7. 'A Prime' is defined as a signal detection measure of sensitivity to the target, regardless of tresponse tendency. This metric is a measure of how good the participant is at detecting target sequences. Scale ranges from 0 to 1 with a higher score indicating a better performance.
Measured: Baseline to 4 months
'Median latency' in CANTAB task 'Rapid Visual Information Processing'
'Rapid Visual Information Processing' task measures 'Sustained attention'. In this task, the screen will display a box which randomly flashes the numbers 2-9. The participant must press the button on the screen to respond when they see a target sequence of 3-5-7. 'Median latency' is defined as the median response latency during assessed blocks where the participant responds correctly. Scale ranges from 100 to 1900 with a lower score indicating a better performance.
Measured: Baseline to 4 months
'Total false alarms' in CANTAB task 'Rapid Visual Information Processing'
'Rapid Visual Information Processing' task measures 'Sustained attention'. In this task, the screen will display a box which randomly flashes the numbers 2-9. The participant must press the button on the screen to respond when they see a target sequence of 3-5-7. 'Total false alarms' is defined as the number of times the participant responds outside the response window of a target sequence. Scale ranges from 0 to 546 with a lower score indicating a better performance.
Measured: Baseline to 4 months
CANTAB Score on 'Raven's colored progressive matrices'
This is a non verbal visual test, assessing the problem solving and reasoning ability. Participants are presented with 36 visual patterns (with one piece missing from the bottom right corner), grouped in three sets of 12 items each. For each visual pattern, participants are presented with various alternative pieces that could complete the puzzle, and have to choose the correct one. Participants have to attempt all 36 items of the task, the final score being the sum of correct answers across the three series. Scale ranges from 0 to 60 with a higher score indicating a better performance.
Measured: Baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge Cognition Ltd
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416245
- Sponsor's protocol ID
- 202379
- Status last verified
- Jun 2015
- First submitted
- 9 Apr 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02416245
- Acronym / sponsor ID
- 202379
- Conditions
- Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge Cognition Ltd
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test beverage powder | Experimental | Dietary Supplement: Beverage powder fortified with micronutrients and Bacopa monnieri extractTest 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 | Placebo comparator | Other: 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 |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beverage powder fortified with micronutrients and Bacopa monnieri extractTest 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 | Test beverage powder |
| 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 | Other | Control beverage powder |
Primary outcome
'Between errors' in CANTAB task 'Spatial working memory'
Time frame: Baseline to 4 months
'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.
'Strategy' in CANTAB task 'Spatial working memory'
Time frame: Baseline to 4 months
'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.
6 secondary outcomes
'Total errors (adjusted)' in CANTAB task 'Paired associate learning'
Time frame: Baseline to 4 months
'Problems solved in minimum moves' in CANTAB task 'Stockings of Cambridge'
Time frame: Baseline to 4 months
'A Prime' in CANTAB task 'Rapid Visual Information Processing'
Time frame: Baseline to 4 months
'Median latency' in CANTAB task 'Rapid Visual Information Processing'
Time frame: Baseline to 4 months
'Total false alarms' in CANTAB task 'Rapid Visual Information Processing'
Time frame: Baseline to 4 months
CANTAB Score on 'Raven's colored progressive matrices'
Time frame: Baseline to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage powder fortified with micronutrients and Bacopa monnieri extract in people with Cognition, run by GlaxoSmithKline at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
'Between errors' in CANTAB task 'Spatial working memory' (time frame: Baseline to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.