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Aronia, Cognition, and Eye Health (ACE)

Not Applicable
Recruiting
Conditions
Cognitive Function
Interventions
Dietary Supplement: Aronia supplementation
Dietary Supplement: Cellulose supplementation
Registration Number
NCT05683002
Lead Sponsor
Maastricht University Medical Center
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).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
44
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
AroniaAronia supplementationAronia Melanocarpa supplementation
ControlCellulose supplementationCellulose supplementation
Primary Outcome Measures
NameTimeMethod
Cognitive FunctionAfter 6 weeks of supplementation

Quantified through the Cambridge Neuropsychological Test Automated Battery (CANTAB). Focus on attention/psychomotor speed, memory, and executive function

Secondary Outcome Measures
NameTimeMethod
Vascular FunctionAt baseline and after 6 weeks of supplementation

Fundus photography

Subjective Eye FatigueAt baseline and after 6 weeks of supplementation

Subjective Eye Fatigue Questionnaire

Eye HealthAt baseline and after 6 weeks of supplementation

Tear fluid collection (volume)

Trial Locations

Locations (1)

Maastricht University

🇳🇱

Maastricht, Netherlands

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