Nutritional Supplement's Effects on Cognition

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

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

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

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.

Connect with a study center

  • Clinical Research Australia

    Duncraig, Western Austrailia 6023
    Australia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.