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NCT Number: NCT05683002

Aronia, Cognition, and Eye Health (ACE)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aronia supplementation

Dietary Supplement

As described in experimental arm

Cellulose supplementation

Dietary Supplement

As described in placebo comparator arm

Primary outcomes

  1. Cognitive Function

    Time frame: After 6 weeks of supplementation

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

Secondary outcomes

  1. Eye Health

    Time frame: At baseline and after 6 weeks of supplementation

    Tear fluid collection (volume)

  2. Subjective Eye Fatigue

    Time frame: At baseline and after 6 weeks of supplementation

    Subjective Eye Fatigue Questionnaire

  3. Vascular Function

    Time frame: At baseline and after 6 weeks of supplementation

    Fundus photography

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • BioActor B.V.

Registry information

Official study title

Aronia, Cognition, and Eye Health

Acronym: ACE

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jan 12, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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