NCT02345187

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Years – 12 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
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

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-01-26
• Last updated: 2015-04-27

Locations

1 site across 1 country: India