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

NCT ID: NCT02345187

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Growth and Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Arm

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

Group Type: ACTIVE_COMPARATOR

Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation

Intervention Type: DIETARY_SUPPLEMENT

The study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks

Control arm

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

Group Type: PLACEBO_COMPARATOR

Non-fortified isocaloric beverage powder

Intervention Type: DIETARY_SUPPLEMENT

The study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks

Interventions

Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation

The study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks

Intervention Type: DIETARY_SUPPLEMENT

Non-fortified isocaloric beverage powder

The study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahajan Imaging Center

UNKNOWN

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

New Delhi, , India

Countries

India

Other Identifiers

RH02384

Identifier Type: OTHER

Identifier Source: secondary_id

202191

Identifier Type: -

Identifier Source: org_study_id