GSK Investigational Site
New Delhi, 110024, India
NCT Number: NCT02345187
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.
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Notify Me11 year–12 year
All sexes
Interventional
Not applicable
New Delhi, 110024, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From baseline to week 17
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
Cognitive fMRI will be conducted at baseline and week 17 to assess the changes regional brain hemodynamic response during working memory. The Participants will be scanned while performing n-back working memory task. They will be presented single digit number (0-9) one-by-one on the screen and will respond to targets and non-targets. Targets will be numbers that match those that occurred on the previous trial (1-back condition), the one before that (2-back condition) or the trial before that (3-back). A control condition will be responding to the target number ('0'). Each condition will be repeated thrice and the total task length will be about eight minutes. fMRI data will be acquired during the task and estimated by convolving hemodynamic response with task related brain ROI
Time frame: From baseline to week 17
Resting state fMRI will be conducted at baseline and week 17 to determine functional connectivity between brain ROIs during resting state
Time frame: From baseline to week 17
Structural MRI will be conducted to define gray and white matter volumes. Changes in gray matter density will be measured at baseline and week 17
Time frame: From baseline to week 17
Rapid visual information processing test from CANTAB will be performed to assess sustained attention at baseline and week 17. The screen will display a box which randomly flashes the numbers 2-9. The participants will press the button on the screen when they see a target sequence of 3-5-7. The test will take approximately 7 min. Mean response data will be extracted and partial correlations accounting for agreed covariates will relate task performance on the CANTAB to the corresponding fMRI task response to assess brain-behavioral relationships
Time frame: From baseline to week 17
Spatial working memory test from CANTAB will be performed to assess working memory at baseline and week 17. The participants will search through a series of boxes until they find a blue chip. They will then move this blue chip to the "home" area on the right hand side of the screen. They will be told to look for the next blue chip which will not be in the same box as before. The number of boxes will be gradually increased from three to eight. Mean response data will be extracted and partial correlations accounting for agreed covariates will relate task performance on the CANTAB to the corresponding fMRI task response to assess brain-behavioral relationships
Time frame: From baseline to week 17
Partial correlations accounting for agreed covariates will be made to relate fMRI response on working memory task to the corresponding task performance on the CANTAB to assess brain-behavioral relationships at baseline and week 17
Time frame: From baseline to week 17
Partial correlations accounting for agreed covariates will be made to relate fMRI response on working memory task to the corresponding task performance on the CANTAB to assess brain-behavioral relationships at baseline and week 17.
GlaxoSmithKline
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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