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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
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
Secondary ID [1] 0 0
PHX 1.2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dietary Supplement 0 0
Cognition 0 0
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in working memory
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Change in Working memory by Corsi Block tasks
Timepoint [2] 0 0
Baseline and Week 12
Primary outcome [3] 0 0
Change in verbal learning and memory
Timepoint [3] 0 0
Baseline and Week 12
Primary outcome [4] 0 0
Change in episodic memory
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change in accuracy of attention
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change in the Everyday Memory
Timepoint [2] 0 0
Baseline, Week 4, Week 8, Week 12
Secondary outcome [3] 0 0
Change in the Perceived Stress score
Timepoint [3] 0 0
Baseline, Week 4, Week 8, Week 12
Secondary outcome [4] 0 0
Change in the World Health Organization score
Timepoint [4] 0 0
Baseline, Week 4, Week 8, Week 12
Secondary outcome [5] 0 0
Change in oxidative stress marker
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Change in plasma Tumor Necrosis Factor-alpha concentrations
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Change in marker of inflammation in the plasma
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Change in plasma Brain-derived neurotropic factor concentrations
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Change in Skin Carotenoid Score
Timepoint [9] 0 0
Baseline and Week 12

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
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Western Austraili
Recruitment hospital [1] 0 0
Clinical Research Australia - Duncraig
Recruitment postcode(s) [1] 0 0
6023 - Duncraig

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmanex
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Clinical Research Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, placebo controlled study, examining the effects of dietary
supplement's effects on cognition and confirming safety.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05941949
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adrian Lopresti, MD
Address 0 0
Clinical Research Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Adrian Lopresti, MD
Address 0 0
Country 0 0
Phone 0 0
61-8-9448-7376
Fax 0 0
Email 0 0
adrian@clinicalresearch.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05941949