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Nutritional Supplement's Effects on Cognition

Recruiting
40 - 70 years of age
Both
Phase N/A

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Overview

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

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.

Eligibility

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

Study details

Dietary Supplement, Cognition, Healthy

NCT05941949

Pharmanex

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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