Nutritional Supplement's Effects on Cognition

Sponsor

Pharmanex (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05941949

Collaborator

Clinical Research Australia (Other)

110

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dietary Supplement Cognition Healthy	Dietary Supplement: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, Prospective, Double Blind, Placebo-Controlled designRandomized, Prospective, Double Blind, Placebo-Controlled design

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Softgels with similar appearance

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Softgel containing: Astaxanthin, Grape Juice Extract, and All Natural Vitamin E	Dietary Supplement: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E 2 softgels per day Other Names: Astaxanthin, Grape Juice Extract, All Natural Vitamin E
Placebo Comparator: Placebo Softgel containing: Olive Oil and Sunflower Lecithin	Dietary Supplement: Placebo 2 softgels per day Other Names: Olive oil

Arm

Intervention/Treatment

Experimental: Active

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

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

2 softgels per day

Other Names:

Astaxanthin, Grape Juice Extract, All Natural Vitamin E

Placebo Comparator: Placebo

Softgel containing: Olive Oil and Sunflower Lecithin

Dietary Supplement: Placebo

2 softgels per day

Other Names:

Olive oil

Outcome Measures

Primary Outcome Measures

Change in working memory [Baseline and Week 12]
Determine change in working memory as measured by the Numeric Working Memory Test
Change in Working memory by Corsi Block tasks [Baseline and Week 12]
Determine if working memory change by doing Corsi blocks task
Change in verbal learning and memory [Baseline and Week 12]
Determine if verbal learning and memory change using total score on Rey Auditory Verbal Learning test trials 1 to 5
Change in episodic memory [Baseline and Week 12]
Determine change in episodic memory as measured by Rey Auditory Verbal Learning Test delayed recall and computerized location learning task

Secondary Outcome Measures

Change in accuracy of attention [Baseline and Week 12]
Determine change inaccuracy of attention as measured by the choice reaction time and digit vigilance task (percent correct)
Change in the Everyday Memory [Baseline, Week 4, Week 8, Week 12]
Determine the change in the Everyday Memory Questionnaire total score
Change in the Perceived Stress score [Baseline, Week 4, Week 8, Week 12]
Determine the change in the Perceived Stress Questionnaire total score
Change in the World Health Organization score [Baseline, Week 4, Week 8, Week 12]
Determine the change in the World Health Organization-5 (WHO-5) score
Change in oxidative stress marker [Baseline and Week 12]
Determine change in plasma malondialdehyde
Change in plasma Tumor Necrosis Factor-alpha concentrations [Baseline and Week 12]
Determine change in plasma Tumor Necrosis Factor concentrations
Change in marker of inflammation in the plasma [Baseline and Week 12]
Determine the change in the plasma marker (interleukin-6-alpha concentrations
Change in plasma Brain-derived neurotropic factor concentrations [Baseline and Week 12]
Determine the change in plasma Brain-derived neurotropic factor concentrations
Change in Skin Carotenoid Score [Baseline and Week 12]
Determine the change in Skin Carotenoid Scores using Raman spectroscopy (BioPhotonic Scanner)

Other Outcome Measures

Change in Ocular Surface Disease Index score [Baseline, Week 4, Week 8, Week 12]
Determine the change in Ocular Surface Disease Index score
Change in diastolic blood pressure measurement (safety measure) [Baseline and Week 12]
Determine change in diastolic blood pressure changes using sphygmomanometer
Change in systolic blood pressure measurement (safety measure) [Baseline and Week 12]
Determine change in systolic blood pressure measurement using sphygmomanometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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