Clinical trial NCT02439983: Brain Imaging Study
Official title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Effects of a Proprietary Nutritional Supplement on Brain Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Health
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: University of Utah
First posted: 2015-05-12
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in MRI Brain scan
timeFrame: Change from Baseline MRI Brain scan at Day 42
Secondary outcomes:
measure: Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)
timeFrame: Change from Baseline anxiety at Day 42
measure: Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)
timeFrame: Change from Baseline depression at Day 42
measure: Change in mood as measured by the Profile of Mood States (POMS)
timeFrame: Change from Baseline mood at Day 42
measure: Change in memory as measured by Logical Memory I and II (subtests from the Wechsler Memory Scale- IV)
timeFrame: Change from Baseline memory at Day 42
measure: Change in fluency as measure by Letter and Category Fluency test
timeFrame: Change from Baseline fluency at Day 42
measure: Change in Chemistry panel
timeFrame: Change from Baseline Chemistry panel at Day 42
measure: Change in RBC fatty acid profile
timeFrame: Change from Baseline RBC fatty acid profile at Day 42
measure: Change in Gene expression
timeFrame: Change from Baseline Gene expression at Day 42
measure: Measurement of polyphenol metabolites in saliva
timeFrame: Day 42
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah - Brain Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Deborah Yurgelun-Todd, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.