Study Results
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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UNKNOWN
NA
110 participants
INTERVENTIONAL
2023-07-05
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
Softgel containing: Astaxanthin, Grape Juice Extract, and All Natural Vitamin E
Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
2 softgels per day
Placebo
Softgel containing: Olive Oil and Sunflower Lecithin
Placebo
2 softgels per day
Interventions
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Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
2 softgels per day
Placebo
2 softgels per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Residing in independent living accommodations
* Subjective report of memory or attention problems by answering 'yes' to the following questions: Do you have problems with your memory, attention, or concentration?
* Non-smoker
* Body Mass Index (BMI) between 18-35 kg/m2
* No plan to commence new treatments over the study period
* Understand, willing and able to comply with all study procedures
* Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the study
Exclusion Criteria
* A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
* Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/malignancy
* Diagnosis of a psychiatric disease (other than mild-to moderate depression of anxiety) and/or neurological condition/disease (e.g. Parkinson's, Alzheimer's disease)
* History of paralysis, stroke or seizures or head injury (with loss of consciousness)
* Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibiters, or steroid medications.
* Taking vitamins or herbal supplements that are reasonably expected to influence study measures
* In the last 6 month, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcome
* Alcohol intake greater than 14 standard drinks per week
* Current or 12-month history of illicit drug abuse
* Pregnant women, women who are Brest feeding, or women who intend to fall pregnant
* Any significant surgeries over the last year
* Planned major lifestyle change in the next 3 months
40 Years
70 Years
ALL
Yes
Sponsors
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Clinical Research Australia
OTHER
Pharmanex
INDUSTRY
Responsible Party
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Principal Investigators
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Adrian Lopresti, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Australia
Locations
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Clinical Research Australia
Duncraig, Western Austrailia, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PHX 1.2
Identifier Type: -
Identifier Source: org_study_id
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