Nutritional Supplement's Effects on Cognition

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy; Cognition; Dietary Supplement
• Intervention / Treatment: Dietary supplement: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adrian Lopresti, MD; Phone Number: 61-8-9448-7376; Email: adrian@clinicalresearch.com.au
• Study Contact Backup: Name: Stephen Smith; Phone Number: 61-8-9448-7376; Email: stephen@clinicalresearch.com.au

Study Locations

• Australia
  • Western Austrailia
    • Duncraig, Western Austrailia, Australia, 6023
      • Recruiting
      • Clinical Research Australia
      • Contact: Adrian Lopresti, MD; Phone Number: 61-8-9448-7376; Email: adrian@clinicalresearch.com.au
      • Contact: Stephen Smith; Phone Number: 61-8-9448-7376; Email: stephen@clinicalresearch.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pharmanex
• Collaborators: Clinical Research Australia
• Investigators: Principal Investigator: Adrian Lopresti, MD, Clinical Research Australia

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Wellbeing; Memory; Cognition; Antioxidant; Dietary Supplement; Mental Stress; Astaxanthin; Grape Juice Extract
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Tocotrienols
• Other Study ID Numbers: PHX 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data. Will only report summary data i.e. means by responses to specific variables.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No