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Brain Imaging Study

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ClinicalTrials.gov Identifier: NCT02439983
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Health Dietary Supplement: Proprietary Nutritional Supplement Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Effects of a Proprietary Nutritional Supplement on Brain Health
Study Start Date : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439983


Locations
United States, Utah
University of Utah - Brain Institute
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Pharmanex
University of Utah
Investigators
Principal Investigator: Deborah Yurgelun-Todd, Ph.D. University of Utah

Responsible Party: Pharmanex
ClinicalTrials.gov Identifier: NCT02439983     History of Changes
Other Study ID Numbers: 14-PHX-0002
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016