Growth and DevelopmentNCT02345187
fMRI Study to Investigate Hemodynamic Changes in Brain Resulting From Supplementation of Bacopa Monnieri Extract and Multiple Micronutrient Supplementation.
A study testing Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation and Non-fortified isocaloric beverage powder in people with Growth and Development, run by GlaxoSmithKline at 1 site in India.
Trial summary
The study will aim to compare the effects of a beverage powder fortified with multiple micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric beverage powder (control product) on cognitive outcomes of attention and working memory. Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth and Development
- What is being tested?
- Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation and Non-fortified isocaloric beverage powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2014to Apr 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 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Voluntary written informed consent from participant's parents/ legally acceptable representative (LAR) and voluntary written assent from the subject and a signed, dated copy of the informed consent and assent forms.
- Right handed, School going children (participants) aged 11-12 years, inclusive
- Satisfactory completion of baseline imaging scan basis participant's ability to stay still, with acceptable MRI/fMRI image quality as determined by technical expert at the imaging centre
- Compliance of participant and participant's parents/LAR with all study procedures and restrictions.
- Participant is able to read and comprehend one of the languages used for cognitive assessment (English or Hindi)
- Participant with Z-scores of Body Mass Index (BMI) for age of >-2 to <+1
Who cannot join
- Child in Care (CiC); A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. A CiC does not include a child who is adopted or has an appointed legal guardian.
- Known or suspected intolerance or hypersensitivity to the study materials, any of their stated ingredients or any known food allergies like nut allergy, gluten allergy or lactose intolerance.
- Severe anemia with hemoglobin<8g/Dl, Attention Deficit Hyperactivity Disorder (ADHD), reading dyslexia or any other behavioral disorder.
- Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit or previous participation in this study.
- Participation in any nutritional study within 6 months prior to the screening visit.
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder
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- Health conditions affecting food metabolism including food allergies, kidney disease, liver disease and/or gastrointestinal diseases.
- Use of concomitant medication that might interfere with the outcome of the study or increases the risk to the participant.
- Currently taking any other health food drinks/beverages or supplements (including nutritional supplements) or has been on supplements within a month prior to study start.
- Participant whose sibling is already a participant of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Multiple Micronutrient (MMN) Fortified Powder Supplemented With Bacopa Monnieri Extract (EBM) on Hemodynamic Responses as Measured by Functional Magnetic Resonance Imaging (fMRI) in Indian School Children (11-12 Yrs; Inclusive) After Approximately 4 Months of Intervention: an Exploratory, Randomized, Double-blind, Controlled Trial
The study will aim to compare the effects of a beverage powder fortified with multiple micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric beverage powder (control product) on cognitive outcomes of attention and working memory.
- Conditions
- Growth and Development
- Being tested
- Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation, Non-fortified isocaloric beverage powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementationDietary supplement
The study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks
Non-fortified isocaloric beverage powderDietary supplement
The study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Entire content of a sachet of the beverage powder fortified with multiple micronutrients and bacopa monnieri extract will be emptied in a graduated drinking tumbler and reconstituted with 180 mL potable lukewarm water. Water will be added to the tumbler gradually with stirring to avoid lump formation. The reconstituted beverage will be administered to the participants orally twice daily for 17 weeks Receives: Dietary Supplement: Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation |
| Control arm | Placebo comparator | Entire content of a sachet of the non-fortified isocaloric beverage powder will be emptied in a graduated drinking tumbler and reconstituted with 180 mL potable lukewarm water. Water will be added to the tumbler gradually with stirring to avoid lump formation. The reconstituted beverage will be administered to the participants orally twice daily for 17 weeks Receives: Dietary Supplement: Non-fortified isocaloric beverage powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in regional brain hemodynamic response during attention, as measured by cognitive Functional Magnetic Resonance Imaging (fMRI)
Cognitive fMRI will be conducted at baseline and week 17 to assess the changes in regional brain hemodynamic response during attention task. Participants will be scanned while performing Sustained Attention to a Response Test (SART). During SART, a single digit (1-9) will be presented for 1 second(s). For first 333 miliseconds (ms), digit will be displayed in black font, then gray font for remaining 1s. Participants will be instructed to press a button when each digit turns gray. SART will have hard and easy block. During 'hard' block participants will be instructed to press the button for every digit except '3'. Whereas, during 'easy' block, they will be told that no 3's will be presented and no response needs to be withheld. Four easy blocks will be alternated with four hard blocks, with 15s rest between each. fMRI data will be acquired during the task and estimated by convolving hemodynamic response with task related brain Region of Interest
Measured: From baseline to week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth and DevelopmentStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mahajan Imaging Center
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345187
- Sponsor's protocol ID
- 202191
- Other IDs
- RH02384
- Status last verified
- Apr 2015
- First submitted
- 19 Jan 2015
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multiple Micronutrient (MMN) Fortified Powder Supplemented With Bacopa Monnieri Extract (EBM) on Hemodynamic Responses as Measured by Functional Magnetic Resonance Imaging (fMRI) in Indian School Children (11-12 Yrs; Inclusive) After Approximately 4 Months of Intervention: an Exploratory, Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT02345187
- Acronym / sponsor ID
- 202191
- Conditions
- Growth and Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Mahajan Imaging Center
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Jan 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 study will aim to compare the effects of a beverage powder fortified with multiple micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric beverage powder (control product) on cognitive outcomes of attention and working memory.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Dietary Supplement: Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementationEntire content of a sachet of the beverage powder fortified with multiple micronutrients and bacopa monnieri extract will be emptied in a graduated drinking tumbler and reconstituted with 180 mL potable lukewarm water. Water will be added to the tumbler gradually with stirring to avoid lump formation. The reconstituted beverage will be administered to the participants orally twice daily for 17 weeks |
| Control arm | Placebo comparator | Dietary Supplement: Non-fortified isocaloric beverage powderEntire content of a sachet of the non-fortified isocaloric beverage powder will be emptied in a graduated drinking tumbler and reconstituted with 180 mL potable lukewarm water. Water will be added to the tumbler gradually with stirring to avoid lump formation. The reconstituted beverage will be administered to the participants orally twice daily for 17 weeks |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Voluntary written informed consent from participant's parents/ legally acceptable representative (LAR) and voluntary written assent from the subject and a signed, dated copy of the informed consent and assent forms.
- Right handed, School going children (participants) aged 11-12 years, inclusive
- Satisfactory completion of baseline imaging scan basis participant's ability to stay still, with acceptable MRI/fMRI image quality as determined by technical expert at the imaging centre
- Compliance of participant and participant's parents/LAR with all study procedures and restrictions.
- Participant is able to read and comprehend one of the languages used for cognitive assessment (English or Hindi)
Key exclusion criteria (10 listed)
- Child in Care (CiC); A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. A CiC does not include a child who is adopted or has an appointed legal guardian.
- Known or suspected intolerance or hypersensitivity to the study materials, any of their stated ingredients or any known food allergies like nut allergy, gluten allergy or lactose intolerance.
- Severe anemia with hemoglobin<8g/Dl, Attention Deficit Hyperactivity Disorder (ADHD), reading dyslexia or any other behavioral disorder.
- Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit or previous participation in this study.
- Participation in any nutritional study within 6 months prior to the screening visit.
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 Bacopa Monnieri Extract and Multiple Micronutrient supplementationThe study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks | Dietary supplement | Treatment Arm |
| Non-fortified isocaloric beverage powderThe study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks | Dietary supplement | Control arm |
Primary outcome
Changes in regional brain hemodynamic response during attention, as measured by cognitive Functional Magnetic Resonance Imaging (fMRI)
Time frame: From baseline to week 17
Cognitive fMRI will be conducted at baseline and week 17 to assess the changes in regional brain hemodynamic response during attention task. Participants will be scanned while performing Sustained Attention to a Response Test (SART). During SART, a single digit (1-9) will be presented for 1 second(s). For first 333 miliseconds (ms), digit will be displayed in black font, then gray font for remaining 1s. Participants will be instructed to press a button when each digit turns gray. SART will have hard and easy block. During 'hard' block participants will be instructed to press the button for every digit except '3'. Whereas, during 'easy' block, they will be told that no 3's will be presented and no response needs to be withheld. Four easy blocks will be alternated with four hard blocks, with 15s rest between each. fMRI data will be acquired during the task and estimated by convolving hemodynamic response with task related brain Region of Interest
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 27 Apr 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 Bacopa Monnieri Extract and Multiple Micronutrient supplementation and Non-fortified isocaloric beverage powder in people with Growth and Development, 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 6 inclusion and 10 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 27 Apr 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?
Changes in regional brain hemodynamic response during attention, as measured by cognitive Functional Magnetic Resonance Imaging (fMRI) (time frame: From baseline to week 17). 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 27 Apr 2015.