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Nutritional Supplement's Effects on Cognition

RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 40 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-07-05

Primary completion: 2024-01-01

Study completion finish: 2024-06-01

Study type

TREATMENT

Phase

Trial ID

NCT05941949

Intervention or treatment

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

DIETARY_SUPPLEMENT: Placebo

Conditions

• Cognition
• Healthy
• Dietary Supplement

Condition: Cognition, Healthy and more
DIETARY_SUPPLEMENT: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E and other drugs
Duncraig, Western Austrailia, Australia
Sponsor: Pharmanex

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Clinical Research Australia

Research sites nearby

Select from list below to view details:

Clinical Research Australia
Duncraig, Western Austrailia, Australia

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?

Participant Group/Arm	Intervention/Treatment
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
PLACEBO_COMPARATOR: Placebo Softgel containing: Olive Oil and Sunflower Lecithin	DIETARY_SUPPLEMENT: Placebo 2 softgels per day

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change in working memory	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	Determine if working memory change by doing Corsi blocks task	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	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	Baseline and Week 12

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change in accuracy of attention	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	Determine the change in the Everyday Memory Questionnaire total score	Baseline, Week 4, Week 8, Week 12
Change in the Perceived Stress score	Determine the change in the Perceived Stress Questionnaire total score	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	Baseline, Week 4, Week 8, Week 12
Change in oxidative stress marker	Determine change in plasma malondialdehyde	Baseline and Week 12
Change in plasma Tumor Necrosis Factor-alpha concentrations	Determine change in plasma Tumor Necrosis Factor concentrations	Baseline and Week 12
Change in marker of inflammation in the plasma	Determine the change in the plasma marker (interleukin-6-alpha concentrations	Baseline and Week 12
Change in plasma Brain-derived neurotropic factor concentrations	Determine the change in plasma Brain-derived neurotropic factor concentrations	Baseline and Week 12
Change in Skin Carotenoid Score	Determine the change in Skin Carotenoid Scores using Raman spectroscopy (BioPhotonic Scanner)	Baseline and Week 12

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Nutritional Supplement's Effects on Cognition