Brain Imaging Study

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study Investigating the Effects of a Proprietary Nutritional Supplement on Brain Health

Conditions
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Brain Health

Intervention / Treatment
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* Dietary Supplement: Proprietary Nutritional Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male and female subjects will be included. Age between 40-60 years inclusive. Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures. Eats 1 or fewer servings of fatty fish per week. BMI < 35 Exclusion Criteria: Current or past neurological illness. Substance abuse or dependence within the prior 60 days. Current depression (HAMD greater than 20) or anxiety disorder (HAMA greater than 18). Current or past history of psychiatric disorder. History of head trauma with loss of consciousness. Contraindication to brain MRI examination. Supplementation with Omega 3, fish oil, or other over the counter supplements including the other bioactive ingredients in the proprietary nutritional supplement, antioxidants and multi-vitamin mineral supplements for the previous 3 months. Plasma Omega3 Index >5% at screening visit. Subject has a known allergy or intolerance to any of the ingredients contained in the proprietary nutritional supplement or placebo. Subject is currently pregnant, planning to become pregnant, or is breastfeeding.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 2 capsules taken by mouth with morning and evening meals.<br>|
| Experimental: Proprietary Nutritional Supplement<br> | Dietary Supplement: Proprietary Nutritional Supplement<br>* 2 capsules taken by mouth with morning and evening meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |