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| ID | Type | Description | Link |
|---|---|---|---|
| RH02384 | Other Identifier | GSK |
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| Name | Class |
|---|---|
| Mahajan Imaging Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Active Comparator | 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 |
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| Control arm | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation | Dietary Supplement | The study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in regional brain hemodynamic response during working memory, as measured by cognitive fMRI | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | New Delhi | 110024 | India |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 23, 2018 | |
| Unrelease | Jun 15, 2018 | |
| Release | Jun 15, 2018 |
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| Non-fortified isocaloric beverage powder | Dietary Supplement | The study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks |
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| From baseline to week 17 |
| Changes in functional hemodynamic response in cognitive network, as measured by resting-state fMRI | Resting state fMRI will be conducted at baseline and week 17 to determine functional connectivity between brain ROIs during resting state | From baseline to week 17 |
| Changes in gray matter density, as measured by structural MRI | 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 | From baseline to week 17 |
| Correlation between performance scores on the Cambridge Neuropsychological Test Automated Battery (CANTAB) attention tasks and performance scores on the fMRI attention tasks | 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 | From baseline to week 17 |
| Correlation between performance scores on the CANTAB working memory tasks and performance scores on the fMRI working memory tasks | 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 | From baseline to week 17 |
| Correlation between the changes in regional brain hemodynamic response during working memory tasks, as measured using cognitive fMRI with the scores of working memory, as measured by the CANTAB | 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 | From baseline to week 17 |
| Correlation between changes in the regional brain hemodynamic response during attention tasks as measured using cognitive fMRI with the scores of attention, as measured by the CANTAB | 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. | From baseline to week 17 |
| Reset | Aug 28, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 23, 2018 | Jun 15, 2018 | |||
| Jun 15, 2018 | Aug 28, 2018 |