Open-Label Study of Omega 3 Oil Supplementation for Aging-Related Cognitive Decline
Condition: Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Aging-related cognitive decline may be affected by brain cholesterol and the health of cell
      membranes. Certain nutritional supplements have been proposed to support membrane health, and
      there is increasing interest in plasmalogens and Omega-3 derived oil supplements to support
      brain health among older adults. The product being investigated in this study is the
      ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring
      fatty acids in higher concentrations than similar products that are commercially available.
      The purpose of this research study is to better understand the effects of ProdromeNeuro
      Omega-3 nutritional supplementation among subjects with age-related cognitive decline.
    

Detailed description: 
      There has been an increasing interest in plasmalogens as a potential therapeutic agent for
      age-related cognitive decline and neurodegenerative conditions, given the growing
      understanding of their involvement in key cellular functions as well as the clinical trends
      observed when plasmalogen levels are depleted. In addition to supporting the structural
      integrity of membranes, these plasmalogens are also involved in a variety of critically
      important cell functions: membrane fusion, ion transport, vesicle formation, and
      oxidation-reduction. Plasmalogen and serum plasmalogen deficiency has been shown to impair
      cellular functions, particularly related to cholesterol processing, and has been implicated
      in Alzheimer's and other diseases. Plasmalogen precursor supplementation has been
      demonstrated as safe and potentially efficacious in preclinical studies and some patient
      populations. In theory, ProdromeNeuro supplementation may yield therapeutic benefits among
      patients with age-related cognitive decline by increasing levels of neuroprotective
      plasmalogens.

      The present study is being undertaken as an open-label study to evaluate the safety and
      tolerability of ProdromeNeuro Omega-3 Oil as an intervention for patients with age-related
      cognitive decline. Baseline and outcome measures in this study utilize validated tests that
      are appropriate for repeated measures. Neurocognitive assessment and serology testing kits to
      evaluate for plasmalogen levels will also be administered at baseline, end of the first
      month, end of the second month, end of the 3 month, and after one month post treatment
      termination.
    

Intervention name(s): ProdromeNeuro Omega 3 Oil Nutritional Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): ProdromeNeuro is an algae-derived Omega 3 oil nutritional supplement product comprised of naturally occurring alkylglycerol and natural fatty acids. ProdromeNeuro functions as a natural plasmalogen precursor which can be administered orally.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aging