Brain Imaging Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Brain Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 capsules taken by mouth with morning and evening meals.

Proprietary Nutritional Supplement

Group Type EXPERIMENTAL

Proprietary Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

2 capsules taken by mouth with morning and evening meals.

Interventions

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Proprietary Nutritional Supplement

2 capsules taken by mouth with morning and evening meals.

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 capsules taken by mouth with morning and evening meals.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes