Brain Health
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProprietary Nutritional Supplement
2 capsules taken by mouth with morning and evening meals.
DIETARY_SUPPLEMENTPlacebo
2 capsules taken by mouth with morning and evening meals.
Sponsors
University of Utah
Pharmanex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MRI Brain scan | Change from Baseline MRI Brain scan at Day 42 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 anxiety as measured by the Hamilton Anxiety Scale (HAM-A) | Change from Baseline anxiety 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 |
| Change in Chemistry panel | Change from Baseline Chemistry panel at Day 42 |
Countries
United States
Outcome results
None listed