Clinical trial NCT05941949: Nutritional Supplement's Effects on Cognition
Official title: An Examination Into the Effects of a Nutraceutical Supplement on Cognition, Stress, and Eye and Skin Health in Adults With Self-reported Cognitive Complaints: a Randomised, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dietary Supplement
Cognition
Healthy
Keywords: Dietary Supplement
Cognition
Memory
Mental Stress
Wellbeing
Antioxidant
Astaxanthin
Grape Juice Extract
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: Clinical Research Australia
First posted: 2023-07-12
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Prospective, Double Blind, Placebo-Controlled design
Primary purpose: TREATMENT

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

Detailed 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 criteria: 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

Primary outcomes:
measure: Change in working memory
timeFrame: Baseline and Week 12
measure: Change in Working memory by Corsi Block tasks
timeFrame: Baseline and Week 12
measure: Change in verbal learning and memory
timeFrame: Baseline and Week 12
measure: Change in episodic memory
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in accuracy of attention
timeFrame: Baseline and Week 12
measure: Change in the Everyday Memory
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in the Perceived Stress score
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in the World Health Organization score
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in oxidative stress marker
timeFrame: Baseline and Week 12
measure: Change in plasma Tumor Necrosis Factor-alpha concentrations
timeFrame: Baseline and Week 12
measure: Change in marker of inflammation in the plasma
timeFrame: Baseline and Week 12
measure: Change in plasma Brain-derived neurotropic factor concentrations
timeFrame: Baseline and Week 12
measure: Change in Skin Carotenoid Score
timeFrame: Baseline and Week 12
Other outcomes:
measure: Change in Ocular Surface Disease Index score
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in diastolic blood pressure measurement (safety measure)
timeFrame: Baseline and Week 12
measure: Change in systolic blood pressure measurement (safety measure)
timeFrame: Baseline and Week 12
Locations:
city: Duncraig
country: Australia
facility: Clinical Research Australia
state: Western Austrailia
Study officials:
affiliation: Clinical Research Australia
name: Adrian Lopresti, MD
role: PRINCIPAL_INVESTIGATOR
References: