Nutritional Supplement's Effects on Cognition

Pharmanex

Status: Enrolling

Conditions: Healthy; Cognition; Dietary Supplement

Treatments: Dietary Supplement: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05941949

PHX 1.2

Details and patient eligibility

About

This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.

Full description

The objective of this prospective, placebo controlled, double-blinded, parallel-group study is to examine the effects of dietary supplement containing grape juice extract, astaxanthin, and vitamin E over 12 week consumption on cognitive performance and self report results based on questionnaires. Furthermore, an evaluation of general well-being, mood, markers of oxidative stress, neurogenesis (BDNF), eye health, skin health, skin carotenoid concentrations, and safety measurements will be assessed.

Enrollment: 110 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health Individuals
• 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

• Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer's Association (NIA/AA) 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Softgel containing: Astaxanthin, Grape Juice Extract, and All Natural Vitamin E

Treatment:

Dietary Supplement: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E

Placebo

Placebo Comparator group

Description:

Softgel containing: Olive Oil and Sunflower Lecithin

Treatment:

Dietary Supplement: Placebo