Nutritional Supplement's Effects on Cognition

NCT ID: NCT05941949

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2024-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Dietary Supplement Cognition Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Prospective, Double Blind, Placebo-Controlled design
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Softgels with similar appearance

Study Groups

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Active

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

2 softgels per day

Placebo

Softgel containing: Olive Oil and Sunflower Lecithin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 softgels per day

Interventions

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

2 softgels per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 softgels per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Astaxanthin, Grape Juice Extract, All Natural Vitamin E Olive oil

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinical Research Australia

OTHER

Sponsor Role collaborator

Pharmanex

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Lopresti, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Australia

Locations

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Clinical Research Australia

Duncraig, Western Austrailia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Adrian Lopresti, MD

Role: CONTACT

61-8-9448-7376

Stephen Smith

Role: CONTACT

61-8-9448-7376

Facility Contacts

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Adrian Lopresti, MD

Role: primary

61-8-9448-7376

Stephen Smith

Role: backup

61-8-9448-7376

Other Identifiers

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PHX 1.2

Identifier Type: -

Identifier Source: org_study_id

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