Aronia, Cognition, and Eye Health (ACE)

NCT05683002 | Active Not Recruiting DMC

• 1 other identifier: BB-04
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Function

Keywords

Supplementation; Cognition; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Eye Health

  At baseline and after 6 weeks of supplementation

• Subjective Eye Fatigue

  At baseline and after 6 weeks of supplementation

• Vascular Function

  At baseline and after 6 weeks of supplementation

Study Arms (2)

Aronia

EXPERIMENTAL

Aronia Melanocarpa supplementation

Dietary Supplement: Aronia supplementation

Control

PLACEBO COMPARATOR

Cellulose supplementation

Dietary Supplement: Cellulose supplementation

Interventions

Aronia supplementation DIETARY_SUPPLEMENT

As described in experimental arm

Aronia

Cellulose supplementation DIETARY_SUPPLEMENT

As described in placebo comparator arm

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• BioActor B.V.: collaborator

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Study Officials

• Jogchum Plat, Prof

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block Randomization
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 12, 2023
• Study Start: December 8, 2022
• Primary Completion: July 26, 2024
• Study Completion: January 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)