Aronia, Cognition, and Eye Health (ACE) (ACE)

Aronia, Cognition, and Eye Health

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

Study Overview

• Status: Recruiting
• Conditions: Cognitive Function
• Intervention / Treatment: Dietary supplement: Aronia supplementation; Dietary supplement: Cellulose supplementation

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).

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanne Ahles, Msc; Phone Number: +31437114555; Email: s.ahles@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht University
    • Contact: Sanne Ahles, Msc; Email: s.ahles@maastrichtuniversity.nl
    • Contact: Jogchum Plat, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aronia; Aronia Melanocarpa supplementation	Dietary supplement: Aronia supplementation; As described in experimental arm
Placebo Comparator: Control; Cellulose supplementation	Dietary supplement: Cellulose supplementation; As described in placebo comparator arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye Health	Tear fluid collection (volume)	At baseline and after 6 weeks of supplementation
Subjective Eye Fatigue	Subjective Eye Fatigue Questionnaire	At baseline and after 6 weeks of supplementation
Vascular Function	Fundus photography	At baseline and after 6 weeks of supplementation

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: BioActor B.V.
• Investigators: Principal Investigator: Jogchum Plat, Prof, Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Supplementation; Cognition; Cognitive Function
• Other Study ID Numbers: BB-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No