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Completed

NCT Number: NCT02439983

Brain Imaging Study

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.

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Key information

Conditions

Brain Health

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah - Brain Institute

Salt Lake City, Utah, 84108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proprietary Nutritional Supplement

Dietary Supplement

2 capsules taken by mouth with morning and evening meals.

Placebo

Dietary Supplement

2 capsules taken by mouth with morning and evening meals.

Primary outcomes

  1. Change in MRI Brain scan

    Time frame: 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 outcomes

  1. Change in anxiety as measured by the Hamilton Anxiety Scale (HAM-A)

    Time frame: Change from Baseline anxiety at Day 42

  2. Change in depression as measured by the Hamilton Depression Rating Scale (HAM-D)

    Time frame: Change from Baseline depression at Day 42

  3. Change in mood as measured by the Profile of Mood States (POMS)

    Time frame: Change from Baseline mood at Day 42

  4. Change in memory as measured by Logical Memory I and II (subtests from the Wechsler Memory Scale- IV)

    Time frame: Change from Baseline memory at Day 42

  5. Change in fluency as measure by Letter and Category Fluency test

    Time frame: Change from Baseline fluency at Day 42

  6. Change in Chemistry panel

    Time frame: Change from Baseline Chemistry panel at Day 42

  7. Change in RBC fatty acid profile

    Time frame: Change from Baseline RBC fatty acid profile at Day 42

  8. Change in Gene expression

    Time frame: Change from Baseline Gene expression at Day 42

  9. Measurement of polyphenol metabolites in saliva

    Time frame: Day 42

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Collaborators

  • University of Utah

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 12, 2015
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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