Aronia, Cognition, and Eye Health (ACE)

Study Overview
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Brief Summary
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There is great interest in improving cognitive performance and eye health as working from home becomes more prominent. Working from home as well as stress in the workplace is an increasing problem. Students and work professional can therefore benefit from improved attention and thus performance in academic and other work environments. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance

Detailed Description
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The shift of on-site education/working to online education/working has had a detrimental impact on motivation to study or work and ultimately on mental health. Moreover, online education has been shown to have a negative effect on concentration, learning, and academic performance. Stress in the workplace is an increasing problem, leading to decreased productivity and overall well-being of working adults. Consequently, there is a great interest in improving cognitive performance, including memory and attention. Previous studies in young adults have mainly focused on acute or short-term (e.g. 1 week) effects of anthocyanin supplementation on cognitive performance. The research hypothesis of the current study is that long term (6 weeks) AME supplementation affects domains of cognitive performance in a randomized, double-blind, placebo controlled, cross-over study in healthy young adults (18-35 years old).

Official Title
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Aronia, Cognition, and Eye Health

Conditions
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Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Aronia supplementation
* Dietary Supplement: Cellulose supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women, aged between 18-35 years BMI between 18-30 kg/m2 Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg Stable body weight (weight gain or loss < 3 kg in the past three months) Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study No difficult venipuncture as evidenced during the screening visit Exclusion Criteria: Smoking or smoking cessation < 12 months Contact lens wearers Past refractive surgery Severe medical conditions, including asthma, chronic obstructive pulmonary disease (COPD), kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease Use of dietary supplements or medication affecting the main outcomes of the study Use of an investigational product within another biomedical intervention trial within the previous month Familial hypercholesterolemia Abuse of drugs More than 3 alcoholic consumptions per day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aronia<br>Aronia Melanocarpa supplementation | Dietary Supplement: Aronia supplementation<br>* As described in experimental arm<br>|
| Placebo Comparator: Control<br>Cellulose supplementation | Dietary Supplement: Cellulose supplementation<br>* As described in placebo comparator arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function | Quantified through the Cambridge Neuropsychological Test Automated Battery (CANTAB). Focus on attention/psychomotor speed, memory, and executive function | After 6 weeks of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye Health | Tear fluid collection (volume) | At baseline and after 6 weeks of supplementation | 
| Subjective Eye Fatigue | Subjective Eye Fatigue Questionnaire | At baseline and after 6 weeks of supplementation | 
| Vascular Function | Fundus photography | At baseline and after 6 weeks of supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supplementation, Cognition, Cognitive Function