Nutritional Supplement's Effects on Cognition

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941949
• Other study ID #: PHX 1.2
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Pharmanex
• Contact: Adrian Lopresti, MD
• Phone: 61-8-9448-7376
• Email: adrian[@]clinicalresearch.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition
• Dietary Supplement
• Healthy

Intervention

Dietary Supplement:
• Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
2 softgels per day
• Placebo
2 softgels per day

Locations

Country	Name	City	State
Australia	Clinical Research Australia	Duncraig	Western Austrailia

Sponsors (2)

Lead Sponsor	Collaborator
Pharmanex	Clinical Research Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Ocular Surface Disease Index score	Determine the change in Ocular Surface Disease Index score	Baseline, Week 4, Week 8, Week 12
Other	Change in diastolic blood pressure measurement (safety measure)	Determine change in diastolic blood pressure changes using sphygmomanometer	Baseline and Week 12
Other	Change in systolic blood pressure measurement (safety measure)	Determine change in systolic blood pressure measurement using sphygmomanometer	Baseline and Week 12
Primary	Change in working memory	Determine change in working memory as measured by the Numeric Working Memory Test	Baseline and Week 12
Primary	Change in Working memory by Corsi Block tasks	Determine if working memory change by doing Corsi blocks task	Baseline and Week 12
Primary	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
Primary	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	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
Secondary	Change in the Everyday Memory	Determine the change in the Everyday Memory Questionnaire total score	Baseline, Week 4, Week 8, Week 12
Secondary	Change in the Perceived Stress score	Determine the change in the Perceived Stress Questionnaire total score	Baseline, Week 4, Week 8, Week 12
Secondary	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
Secondary	Change in oxidative stress marker	Determine change in plasma malondialdehyde	Baseline and Week 12
Secondary	Change in plasma Tumor Necrosis Factor-alpha concentrations	Determine change in plasma Tumor Necrosis Factor concentrations	Baseline and Week 12
Secondary	Change in marker of inflammation in the plasma	Determine the change in the plasma marker (interleukin-6-alpha concentrations	Baseline and Week 12
Secondary	Change in plasma Brain-derived neurotropic factor concentrations	Determine the change in plasma Brain-derived neurotropic factor concentrations	Baseline and Week 12
Secondary	Change in Skin Carotenoid Score	Determine the change in Skin Carotenoid Scores using Raman spectroscopy (BioPhotonic Scanner)	Baseline and Week 12