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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05941949
Registration number
NCT05941949
Ethics application status
Date submitted
26/05/2023
Date registered
12/07/2023
Date last updated
13/07/2023
Titles & IDs
Public title
Nutritional Supplement's Effects on Cognition
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Scientific 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
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Secondary ID [1]
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PHX 1.2
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dietary Supplement
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Cognition
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Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
Other interventions - Placebo
Experimental: Active - Softgel containing: Astaxanthin, Grape Juice Extract, and All Natural Vitamin E
Placebo Comparator: Placebo - Softgel containing: Olive Oil and Sunflower Lecithin
Other interventions: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
2 softgels per day
Other interventions: Placebo
2 softgels per day
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in working memory
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Assessment method [1]
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Determine change in working memory as measured by the Numeric Working Memory Test
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Timepoint [1]
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Baseline and Week 12
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Primary outcome [2]
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Change in Working memory by Corsi Block tasks
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Assessment method [2]
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Determine if working memory change by doing Corsi blocks task
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Timepoint [2]
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Baseline and Week 12
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Primary outcome [3]
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Change in verbal learning and memory
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Assessment method [3]
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Determine if verbal learning and memory change using total score on Rey Auditory Verbal Learning test trials 1 to 5
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Timepoint [3]
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Baseline and Week 12
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Primary outcome [4]
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Change in episodic memory
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Assessment method [4]
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Determine change in episodic memory as measured by Rey Auditory Verbal Learning Test delayed recall and computerized location learning task
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [1]
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Change in accuracy of attention
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Assessment method [1]
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Determine change inaccuracy of attention as measured by the choice reaction time and digit vigilance task (percent correct)
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Change in the Everyday Memory
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Assessment method [2]
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Determine the change in the Everyday Memory Questionnaire total score
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Timepoint [2]
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Baseline, Week 4, Week 8, Week 12
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Secondary outcome [3]
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Change in the Perceived Stress score
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Assessment method [3]
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Determine the change in the Perceived Stress Questionnaire total score
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Timepoint [3]
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Baseline, Week 4, Week 8, Week 12
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Secondary outcome [4]
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Change in the World Health Organization score
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Assessment method [4]
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Determine the change in the World Health Organization-5 (WHO-5) score
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Timepoint [4]
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Baseline, Week 4, Week 8, Week 12
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Secondary outcome [5]
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Change in oxidative stress marker
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Assessment method [5]
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Determine change in plasma malondialdehyde
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Timepoint [5]
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Baseline and Week 12
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Secondary outcome [6]
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Change in plasma Tumor Necrosis Factor-alpha concentrations
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Assessment method [6]
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Determine change in plasma Tumor Necrosis Factor concentrations
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Timepoint [6]
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Baseline and Week 12
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Secondary outcome [7]
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Change in marker of inflammation in the plasma
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Assessment method [7]
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Determine the change in the plasma marker (interleukin-6-alpha concentrations
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Timepoint [7]
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Baseline and Week 12
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Secondary outcome [8]
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Change in plasma Brain-derived neurotropic factor concentrations
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Assessment method [8]
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Determine the change in plasma Brain-derived neurotropic factor concentrations
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Change in Skin Carotenoid Score
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Assessment method [9]
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Determine the change in Skin Carotenoid Scores using Raman spectroscopy (BioPhotonic Scanner)
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Timepoint [9]
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Baseline and Week 12
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Eligibility
Key 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
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Minimum age
40
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
110
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
Western Austraili
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Recruitment hospital [1]
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Clinical Research Australia - Duncraig
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Recruitment postcode(s) [1]
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6023 - Duncraig
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pharmanex
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Clinical Research Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a prospective, placebo controlled study, examining the effects of dietary
supplement's effects on cognition and confirming safety.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05941949
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Adrian Lopresti, MD
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Address
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Clinical Research Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Adrian Lopresti, MD
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Address
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Country
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Phone
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61-8-9448-7376
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05941949
Download to PDF