The Effects of Blackcurrant Supplementation on Eye Health: a Randomized, Double Blind, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change from baseline in symptoms of computer vision syndrome on day 70.
研究概览
简要总结
The purpose of this study is to evaluate the potential for supplementation with black currant to support eye health among otherwise healthy adult women who spend 6+ hours per day using digital screens.
详细描述
Women who are informed about the study and provide informed consent will be randomized to one of two groups: supplement and placebo. Group assignment will be a 1:1 ratio to supplement (455mg of blackcurrant standardized to 50mg anthocyanins in 2 capsules/day) or placebo (2 capsules/day). Outcomes will be assessed at baseline and again on day 70.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the individuals providing informed consent are masked.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 30-60
- •Lives in the United States
- •Employed full time in an online work environment OR enrolled full time in an online learning environment (average of 6+ hours per day)
- •Ability to understand study instructions
- •Ability to provide informed consent
- •Residence within 100 miles of the study center
排除标准
- •Low blood pressure
- •Uncontrolled hypertension (i.e. systolic/diastolic blood pressure > 140/90)
- •Uncontrolled diabetes (i.e. fasting blood glucose >180mg/dl)
- •Any blood clotting disorder
- •Ocular disease
- •Best corrected visual acuity <20/30
- •Cataracts
- •Renal disease
- •Active hepatitis or cirrhosis
- •Acute or chronic infectious disease
- •Breastfeeding
- •Currently trying to conceive
- •Surgical or other invasive procedure planned within the intervention period
结局指标
主要结局
Change from baseline in symptoms of computer vision syndrome on day 70.
时间窗: Baseline and day 70
The Computer Vision Syndrome Questionnaire is a validated self reported instrument assessing computer vision symptoms. The scale measures the presence or absence of 16 symptoms producing scores from 0-16. Higher scores indicate more symptoms.
Change from baseline in visual fatigue on day 70.
时间窗: Baseline and day 70
The Visual Fatigue scale is a validated self reported instrument assessing visual fatigue symptoms. It is a 6-question scale which asks about immediate symptoms (such as dry eyes). Participants rank their symptoms on a likert scale scored from 1-7, with higher scores indicating more severe symptoms.
Change from baseline in computer vision symptoms on day 70.
时间窗: Baseline and day 70
The Computer Vision Symptom scale is a validated self reported instrument assessing computer vision symptoms. The scale measures 17 symptom domains, with scores ranging from 1-4 to 1-7. On each domain, higher scores indicate greater severity.
Change from baseline in ocular discomfort on day 70.
时间窗: Baseline and day 70
The Ocular Discomfort scale is a validated self reported instrument assessing ocular discomfort symptoms. The scale contains 6 domains with a combination of likert scale (ranging from 1-7) and dichotomous (yes/no) questions. Higher scores indicate greater visual fatigue.
次要结局
未报告次要终点