Clinical trial NCT05683002: Aronia, Cognition, and Eye Health (ACE)
Official title: Aronia, Cognition, and Eye Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Function
Keywords: Supplementation
Cognition
Cognitive Function
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: BioActor B.V.
First posted: 2023-01-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Function
timeFrame: After 6 weeks of supplementation
Secondary outcomes:
measure: Eye Health
timeFrame: At baseline and after 6 weeks of supplementation
measure: Subjective Eye Fatigue
timeFrame: At baseline and after 6 weeks of supplementation
measure: Vascular Function
timeFrame: At baseline and after 6 weeks of supplementation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Jogchum Plat, Prof
role: PRINCIPAL_INVESTIGATOR
References: