Nutritional Supplement's Effects on Cognition

July 11, 2023 updated by: Pharmanex

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in working memory
Time Frame: Baseline and Week 12
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
Time Frame: Baseline and Week 12
Determine if working memory change by doing Corsi blocks task
Baseline and Week 12
Change in verbal learning and memory
Time Frame: Baseline and Week 12
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
Time Frame: Baseline and Week 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in accuracy of attention
Time Frame: Baseline and Week 12
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
Time Frame: Baseline, Week 4, Week 8, Week 12
Determine the change in the Everyday Memory Questionnaire total score
Baseline, Week 4, Week 8, Week 12
Change in the Perceived Stress score
Time Frame: Baseline, Week 4, Week 8, Week 12
Determine the change in the Perceived Stress Questionnaire total score
Baseline, Week 4, Week 8, Week 12
Change in the World Health Organization score
Time Frame: Baseline, Week 4, Week 8, Week 12
Determine the change in the World Health Organization-5 (WHO-5) score
Baseline, Week 4, Week 8, Week 12
Change in oxidative stress marker
Time Frame: Baseline and Week 12
Determine change in plasma malondialdehyde
Baseline and Week 12
Change in plasma Tumor Necrosis Factor-alpha concentrations
Time Frame: Baseline and Week 12
Determine change in plasma Tumor Necrosis Factor concentrations
Baseline and Week 12
Change in marker of inflammation in the plasma
Time Frame: Baseline and Week 12
Determine the change in the plasma marker (interleukin-6-alpha concentrations
Baseline and Week 12
Change in plasma Brain-derived neurotropic factor concentrations
Time Frame: Baseline and Week 12
Determine the change in plasma Brain-derived neurotropic factor concentrations
Baseline and Week 12
Change in Skin Carotenoid Score
Time Frame: Baseline and Week 12
Determine the change in Skin Carotenoid Scores using Raman spectroscopy (BioPhotonic Scanner)
Baseline and Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Ocular Surface Disease Index score
Time Frame: Baseline, Week 4, Week 8, Week 12
Determine the change in Ocular Surface Disease Index score
Baseline, Week 4, Week 8, Week 12
Change in diastolic blood pressure measurement (safety measure)
Time Frame: Baseline and Week 12
Determine change in diastolic blood pressure changes using sphygmomanometer
Baseline and Week 12
Change in systolic blood pressure measurement (safety measure)
Time Frame: Baseline and Week 12
Determine change in systolic blood pressure measurement using sphygmomanometer
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmanex

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinical Research Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrian Lopresti, MD, Clinical Research Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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