Brain Imaging Study

Brain Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439983
• Other study ID #: 14-PHX-0002
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: August 2, 2016
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Pharmanex
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Brain Health

Intervention

Dietary Supplement:
• Proprietary Nutritional Supplement
2 capsules taken by mouth with morning and evening meals.
• Placebo
2 capsules taken by mouth with morning and evening meals.

Locations

Country	Name	City	State
United States	University of Utah - Brain Institute	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Pharmanex	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)		Change from Baseline anxiety at Day 42	No
Secondary	Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)		Change from Baseline depression at Day 42	No
Secondary	Change in mood as measured by the Profile of Mood States (POMS)		Change from Baseline mood at Day 42	No
Secondary	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	No
Secondary	Change in fluency as measure by Letter and Category Fluency test		Change from Baseline fluency at Day 42	No
Secondary	Change in Chemistry panel		Change from Baseline Chemistry panel at Day 42	Yes
Secondary	Change in RBC fatty acid profile		Change from Baseline RBC fatty acid profile at Day 42	No
Secondary	Change in Gene expression		Change from Baseline Gene expression at Day 42	No
Secondary	Measurement of polyphenol metabolites in saliva		Day 42	No