Dietary SupplementNCT05941949
Nutritional Supplement's Effects on Cognition
A study testing Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E in people with Dietary Supplement and Cognition, run by Pharmanex at 1 site in Australia.
Trial summary
This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplement, Cognition, Healthy
- What is being tested?
- Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Jul 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Clinical Research Australia
Duncraig, Western Austrailia, 6023
Adrian Lopresti, MD, 61-8-9448-7376, adrian@clinicalresearch.com.au
Stephen Smith, 61-8-9448-7376, stephen@clinicalresearch.com.au
About this study
Official 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
This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.
Read the 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.
- Conditions
- Dietary Supplement, Cognition, Healthy
- Being tested
- Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E, Placebo
- Keywords
- Dietary Supplement, Cognition, Memory, Mental Stress, Wellbeing, Antioxidant, Astaxanthin, Grape Juice Extract
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin EDietary supplement
Also called Astaxanthin, Grape Juice Extract, All Natural Vitamin E
2 softgels per day
PlaceboDietary supplement
Also called Olive oil
2 softgels per day
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Softgel containing: Astaxanthin, Grape Juice Extract, and All Natural Vitamin E Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in working memory
Determine change in working memory as measured by the Numeric Working Memory Test
Measured: Baseline and Week 12
Change in Working memory by Corsi Block tasks
Determine if working memory change by doing Corsi blocks task
Measured: 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
Measured: 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
Measured: Baseline and Week 12
Secondary outcomes (9)
Change in accuracy of attention
Determine change inaccuracy of attention as measured by the choice reaction time and digit vigilance task (percent correct)
Measured: Baseline and Week 12
Change in the Everyday Memory
Determine the change in the Everyday Memory Questionnaire total score
Measured: Baseline, Week 4, Week 8, Week 12
Change in the Perceived Stress score
Determine the change in the Perceived Stress Questionnaire total score
Measured: Baseline, Week 4, Week 8, Week 12
Change in the World Health Organization score
Determine the change in the World Health Organization-5 (WHO-5) score
Measured: Baseline, Week 4, Week 8, Week 12
Change in oxidative stress marker
Determine change in plasma malondialdehyde
Measured: Baseline and Week 12
Change in plasma Tumor Necrosis Factor-alpha concentrations
Determine change in plasma Tumor Necrosis Factor concentrations
Measured: Baseline and Week 12
Change in marker of inflammation in the plasma
Determine the change in the plasma marker (interleukin-6-alpha concentrations
Measured: Baseline and Week 12
Change in plasma Brain-derived neurotropic factor concentrations
Determine the change in plasma Brain-derived neurotropic factor concentrations
Measured: Baseline and Week 12
Change in Skin Carotenoid Score
Determine the change in Skin Carotenoid Scores using Raman spectroscopy (BioPhotonic Scanner)
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start5 Jul 2023
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Prospective, Double Blind, Placebo-Controlled design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Australia
- Responsible party
- Sponsor
- Investigators
- Adrian Lopresti, MD, Principal investigator, Clinical Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941949
- Sponsor's protocol ID
- PHX 1.2
- Status last verified
- Jul 2023
- First submitted
- 26 May 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data. Will only report summary data i.e. means by responses to specific variables.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05941949
- Acronym / sponsor ID
- PHX 1.2
- Conditions
- Dietary Supplement, Cognition, Healthy
- Keywords
- Dietary Supplement, Cognition, Memory, Mental Stress, Wellbeing, Antioxidant, Astaxanthin, Grape Juice Extract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Australia
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Prospective, Double Blind, Placebo-Controlled design
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin ESoftgel containing: Astaxanthin, Grape Juice Extract, and All Natural Vitamin E |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoftgel containing: Olive Oil and Sunflower Lecithin |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin EAlso: Astaxanthin, Grape Juice Extract, All Natural Vitamin E2 softgels per day | Dietary supplement | Active |
| PlaceboAlso: Olive oil2 softgels per day | Dietary supplement | Placebo |
Primary outcome
Change in working memory
Time frame: Baseline and Week 12
Determine change in working memory as measured by the Numeric Working Memory Test
Change in Working memory by Corsi Block tasks
Time frame: Baseline and Week 12
Determine if working memory change by doing Corsi blocks task
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
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
9 secondary outcomes
Change in accuracy of attention
Time frame: Baseline and Week 12
Change in the Everyday Memory
Time frame: Baseline, Week 4, Week 8, Week 12
Change in the Perceived Stress score
Time frame: Baseline, Week 4, Week 8, Week 12
Change in the World Health Organization score
Time frame: Baseline, Week 4, Week 8, Week 12
Change in oxidative stress marker
Time frame: Baseline and Week 12
Change in plasma Tumor Necrosis Factor-alpha concentrations
Time frame: Baseline and Week 12
Change in marker of inflammation in the plasma
Time frame: Baseline and Week 12
Change in plasma Brain-derived neurotropic factor concentrations
Time frame: Baseline and Week 12
Change in Skin Carotenoid Score
Time frame: Baseline and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No. No plan to share individual participant data. Will only report summary data i.e. means by responses to specific variables.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Lopresti, MD principal investigator
Clinical Research Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E in people with Dietary Supplement and Cognition, run by Pharmanex at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Lopresti, MD (61-8-9448-7376, adrian@clinicalresearch.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in working memory (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.