Last updated: July 11, 2023
Sponsor: Pharmanex
Overall Status: Active - Recruiting
Phase
N/A
Condition
Brain Function
Treatment
Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
Placebo
Clinical Study ID
NCT05941949
PHX 1.2
Ages 40-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Health Individuals
- Residing in independent living accommodations
- Subjective report of memory or attention problems by answering 'yes' to the followingquestions: 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 allpertinent aspects of the study
Exclusion
Exclusion Criteria:
- Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer'sAssociation (NIA/AA) criteria
- A score below the 5th percentile for age, education, and gender on the TelephoneInterview for Cognitive Status (TICS-M)
- Suffering from recently diagnosed or unmanaged medical conditions including but notlimited 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 studymeasures
- In the last 6 month, commenced or changed the dose of nutritional and/or herbalsupplements 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
Study Design
Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
Phase:
Study Start date:
July 05, 2023
Estimated Completion Date:
June 30, 2024
Study Description
Connect with a study center
Clinical Research Australia
Duncraig, Western Austrailia 6023
AustraliaActive - Recruiting
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