Aronia, Cognition, and Eye Health (ACE)

NCT ID: NCT05683002

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2026-01-31

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).

Conditions

Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Aronia

Aronia Melanocarpa supplementation

Group Type: EXPERIMENTAL

Aronia supplementation

Intervention Type: DIETARY_SUPPLEMENT

As described in experimental arm

Control

Cellulose supplementation

Group Type: PLACEBO_COMPARATOR

Cellulose supplementation

Intervention Type: DIETARY_SUPPLEMENT

As described in placebo comparator arm

Interventions

Aronia supplementation

As described in experimental arm

Intervention Type: DIETARY_SUPPLEMENT

Cellulose supplementation

As described in placebo comparator arm

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioActor B.V.

INDUSTRY

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jogchum Plat, Prof

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

BB-04

Identifier Type: -

Identifier Source: org_study_id