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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Growth and Development

Intervention / Treatment
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* Dietary Supplement: Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation
* Dietary Supplement: Non-fortified isocaloric beverage powder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Arm<br>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 | Dietary Supplement: Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation<br>* The study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks<br>|
| Placebo Comparator: Control arm<br>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 | Dietary Supplement: Non-fortified isocaloric beverage powder<br>* The study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From baseline to week 17 |