Brain Imaging Study

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Health
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Proprietary Nutritional Supplement

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah - Brain Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 2 capsules taken by mouth with morning and evening meals.
Experimental: Proprietary Nutritional Supplement	Dietary supplement: Proprietary Nutritional Supplement; 2 capsules taken by mouth with morning and evening meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)	Change from Baseline anxiety at Day 42
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 Chemistry panel	Change from Baseline Chemistry panel 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

Collaborators and Investigators

• Sponsor: Pharmanex
• Collaborators: University of Utah
• Investigators: Principal Investigator: Deborah Yurgelun-Todd, Ph.D., University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): August 3, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 14-PHX-0002