Brain Imaging Study

Pharmanex

Status

Completed

Conditions

Brain Health

Treatments

Dietary Supplement: Proprietary Nutritional Supplement

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02439983

14-PHX-0002

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.