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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
80
The study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks
The study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks
GSK Investigational Site
New Delhi, India
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
Time frame: From baseline to week 17
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