Nutritional Supplement's Effects on Cognition

NCT05941949 | Unknown

• 1 other identifier: PHX 1.2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dietary Supplement; Cognition; Healthy

Keywords

Dietary Supplement; Cognition; Memory; Mental Stress; Wellbeing; Antioxidant; Astaxanthin; Grape Juice Extract

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Change in accuracy of attention

  Baseline and Week 12

• Change in the Everyday Memory

  Baseline, Week 4, Week 8, Week 12

• Change in the Perceived Stress score

  Baseline, Week 4, Week 8, Week 12

• Change in the World Health Organization score

  Baseline, Week 4, Week 8, Week 12

• Change in oxidative stress marker

  Baseline and Week 12

Other Outcomes (3)

• Change in Ocular Surface Disease Index score

  Baseline, Week 4, Week 8, Week 12

• Change in diastolic blood pressure measurement (safety measure)

  Baseline and Week 12

• Change in systolic blood pressure measurement (safety measure)

  Baseline and Week 12

Study Arms (2)

Active

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Softgel containing: Olive Oil and Sunflower Lecithin

Dietary Supplement: Placebo

Interventions

Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E DIETARY_SUPPLEMENT

2 softgels per day

Also known as: Astaxanthin, Grape Juice Extract, All Natural Vitamin E

Active

Placebo DIETARY_SUPPLEMENT

2 softgels per day

Also known as: Olive oil

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanex: lead
• Clinical Research Australia: collaborator

Study Sites (1)

Clinical Research Australia

Duncraig, Western Austrailia, 6023, Australia

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Interventions

astaxanthine; Olive Oil

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Adrian Lopresti, MD

  Clinical Research Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Lopresti, MD

CONTACT

61-8-9448-7376; adrian@clinicalresearch.com.au

Stephen Smith

CONTACT

61-8-9448-7376; stephen@clinicalresearch.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Softgels with similar appearance
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Prospective, Double Blind, Placebo-Controlled design

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 12, 2023
• Study Start: July 5, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)