Clinical trial NCT02345187: fMRI Study to Investigate Hemodynamic Changes in Brain Resulting From Supplementation of Bacopa Monnieri Extract and Multiple Micronutrient Supplementation.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Development
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Mahajan Imaging Center
First posted: 2015-01-26
Enrollment: 80
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Changes in regional brain hemodynamic response during attention, as measured by cognitive Functional Magnetic Resonance Imaging (fMRI)
timeFrame: From baseline to week 17
Secondary outcomes:
Other outcomes:
measure: Changes in regional brain hemodynamic response during working memory, as measured by cognitive fMRI
timeFrame: From baseline to week 17
measure: Changes in functional hemodynamic response in cognitive network, as measured by resting-state fMRI
timeFrame: From baseline to week 17
measure: Changes in gray matter density, as measured by structural MRI
timeFrame: From baseline to week 17
measure: Correlation between performance scores on the Cambridge Neuropsychological Test Automated Battery (CANTAB) attention tasks and performance scores on the fMRI attention tasks
timeFrame: From baseline to week 17
measure: Correlation between performance scores on the CANTAB working memory tasks and performance scores on the fMRI working memory tasks
timeFrame: From baseline to week 17
measure: Correlation between the changes in regional brain hemodynamic response during working memory tasks, as measured using cognitive fMRI with the scores of working memory, as measured by the CANTAB
timeFrame: From baseline to week 17
measure: Correlation between changes in the regional brain hemodynamic response during attention tasks as measured using cognitive fMRI with the scores of attention, as measured by the CANTAB
timeFrame: From baseline to week 17
Locations:
city: New Delhi
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: