Brain Imaging Study

Not Applicable

Completed

• Conditions: Brain Health
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Proprietary Nutritional Supplement

• Registration Number: NCT02439983
• Lead Sponsor: Pharmanex

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Proprietary Nutritional Supplement	Proprietary Nutritional Supplement	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)	Change from Baseline depression at Day 42
Change in Chemistry panel	Change from Baseline Chemistry panel at Day 42
Measurement of polyphenol metabolites in saliva	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 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
Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)	Change from Baseline anxiety at Day 42

Trial Locations

Locations (1)

University of Utah - Brain Institute; 🇺🇸 Salt Lake City, Utah, United States