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| Name | Class |
|---|---|
| University of Utah | OTHER |
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The study is designed to evaluate the effects of the proprietary nutritional supplement on cognition, mood, and brain imaging parameters following a relatively short period of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Proprietary Nutritional Supplement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proprietary Nutritional Supplement | Dietary Supplement | 2 capsules taken by mouth with morning and evening meals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in MRI Brain scan | Determine differences in brain metabolism, brain connectivity, or brain structure. Highlight regional brain changes between pre and post chronic supplementation with a proprietary nutritional formula. | Change from Baseline MRI Brain scan at Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A) | Change from Baseline anxiety at Day 42 | |
| Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D) | Change from Baseline depression at Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Yurgelun-Todd, Ph.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah - Brain Institute | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32335159 | Derived | Mastaloudis A, Sheth C, Hester SN, Wood SM, Prescot A, McGlade E, Renshaw PF, Yurgelun-Todd DA. Supplementation with a putative calorie restriction mimetic micronutrient blend increases glutathione concentrations and improves neuroenergetics in brain of healthy middle-aged men and women. Free Radic Biol Med. 2020 Jun;153:112-121. doi: 10.1016/j.freeradbiomed.2020.04.017. Epub 2020 Apr 23. |
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| Placebo | Dietary Supplement | 2 capsules taken by mouth with morning and evening meals. |
|
| Change in mood as measured by the Profile of Mood States (POMS) | Change from Baseline mood at Day 42 |
| Change in memory as measured by Logical Memory I and II (subtests from the Wechsler Memory Scale- IV) | Change from Baseline memory at Day 42 |
| Change in fluency as measure by Letter and Category Fluency test | Change from Baseline fluency at Day 42 |
| Change in Chemistry panel | Change from Baseline Chemistry panel at Day 42 |
| Change in RBC fatty acid profile | Change from Baseline RBC fatty acid profile at Day 42 |
| Change in Gene expression | Change from Baseline Gene expression at Day 42 |
| Measurement of polyphenol metabolites in saliva | Day 42 |