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临床试验/NCT05683002
NCT05683002进行中(未招募)不适用

Aronia, Cognition, and Eye Health

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年12月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
44
试验地点
1
主要终点
Cognitive Function

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Block Randomization

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control

Placebo Comparator

Cellulose supplementation

干预措施: Cellulose supplementation (Dietary Supplement)

Aronia

Experimental

Aronia Melanocarpa supplementation

干预措施: Aronia supplementation (Dietary Supplement)

结局指标

主要结局

Cognitive Function

时间窗: After 6 weeks of supplementation

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

次要结局

  • Subjective Eye Fatigue(At baseline and after 6 weeks of supplementation)
  • Eye Health(At baseline and after 6 weeks of supplementation)
  • Vascular Function(At baseline and after 6 weeks of supplementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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