Aronia, Cognition, and Eye Health (ACE)

Cognitive Function Clinical Trial

— ACE  

Official title:

Aronia, Cognition, and Eye Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683002
• Other study ID #: BB-04
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Maastricht University Medical Center
• Contact: Sanne Ahles, Msc
• Phone: +31437114555
• Email: s.ahles[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Dietary Supplement:
• Aronia supplementation
As described in experimental arm
• Cellulose supplementation
As described in placebo comparator arm

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	BioActor B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Eye Health	Tear fluid collection (volume)	At baseline and after 6 weeks of supplementation
Secondary	Subjective Eye Fatigue	Subjective Eye Fatigue Questionnaire	At baseline and after 6 weeks of supplementation
Secondary	Vascular Function	Fundus photography	At baseline and after 6 weeks of supplementation