fMRI Study to Investigate Hemodynamic Changes in Brain Resulting From Supplementation of Bacopa Monnieri Extract and Multiple Micronutrient Supplementation.

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.

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.