Aronia, Cognition, and Eye Health (ACE)

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05683002
Collaborator
BioActor B.V. (Industry)
36
1
2
18.8
1.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Aronia supplementation
  • Dietary Supplement: Cellulose supplementation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Block Randomization
Primary Purpose:
Prevention
Official Title:
Aronia, Cognition, and Eye Health
Actual Study Start Date :
Dec 8, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cognitive Function [After 6 weeks of supplementation]

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

Secondary Outcome Measures

  1. Eye Health [At baseline and after 6 weeks of supplementation]

    Tear fluid collection (volume)

  2. Subjective Eye Fatigue [At baseline and after 6 weeks of supplementation]

    Subjective Eye Fatigue Questionnaire

  3. Vascular Function [At baseline and after 6 weeks of supplementation]

    Fundus photography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Maastricht Netherlands

Sponsors and Collaborators

  • Maastricht University Medical Center
  • BioActor B.V.

Investigators

  • Principal Investigator: Jogchum Plat, Prof, Maastricht University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT05683002
Other Study ID Numbers:
  • BB-04
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maastricht University Medical Center

Study Results

No Results Posted as of Jan 12, 2023