Open-Label Study of Omega 3 Oil Supplementation for Aging-Related Cognitive Decline

Neurological Associates of West Los Angeles

Status: Completed

Conditions: Cognitive Decline

Treatments: Dietary Supplement: ProdromeNeuro Omega 3 Oil Nutritional Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04484454

ProdromeNeuro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cognitive decline due to aging-related changes
• Clinical Dementia Rating stage of mild dementia 0.5 through moderate dementia CDR stages 1 and 2

Exclusion criteria

• Subjects unable to give informed consent
• Cognitive decline clearly related to an acute illness
• Subjects taking anticoagulants and anti-platelet agents
• Advanced terminal illness
• Any active cancer or chemotherapy
• Any other neoplastic illness or illness characterized by neovascularity

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Omega 3 Oil Supplementation

Experimental group

Description:

Following all necessary screening, patients will be provided with the ProdromeNeuro Omega-3 oil supplement and instructed to consume the equivalent of 1 cc of the oil supplement per day for the first month, followed by 2 cc of the supplement/day for the second month, and finally ending with 4 cc/day of the supplement for the third month. Neurocognitive assessment and serology testing will take place at baseline, end of month 1, end of month 2, end of month 3, and one month post intervention-termination.

Treatment:

Dietary Supplement: ProdromeNeuro Omega 3 Oil Nutritional Supplement