Placebo-controlled Cross-over Studies Examining Blueberries Effects on Dark Vision and Recovery After Photo-bleaching
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Rate of vision adaptation to low light after blueberry juice and placebo ingestion for 3 weeks (S2).
研究概览
简要总结
Clinical evidence for effects of plant anthocyanins on vision, and particularly night vision is controversial. Two clinical trials were conducted to investigate whether blueberry juice consumption affected visual dark adaptation, functional night vision, and recovery after photo-bleaching of the retina. One trial (S2) employed a 3 week intervention and washout period, and two doses of blueberries plus a placebo. The other trial (L1) employed a 12 week intervention plus an 8 week washout and tested one blueberry juice dose against a juice placebo.
详细描述
Vision Tests: 1. Dark adaptometry, 2. scotopic visual acuity, 3. scotopic contrast sensitivity, 4. rod/cone conversion, 5. recovery after retinal photobleaching
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •visual acuity better than 6/7.5 on EDTRS acuity chart at 2.5m
- •visual contrast sensitivity within normal range at 2.5m as tested on Visteck 3000
- •stereo acuity better than 80 seconds of arc on Frisby stereoacuity test
- •no ocular history other than refractive glasses
- •no family history of eye disease
排除标准
- •family history of retinal degeneration, glaucoma, diabetes, hypertension, cataract, or amblyopia (dimness in vision).
- •evidence in subject (upon examination) of amblyopia (dimness in vision), manifest strabismus (unable to focus both eyes on one spot), or anisotropia (non-uniform responsiveness between both eyes).
- •intraocular pressure above 21mmHG from an average of three measures using Mentor tonopen-XL
结局指标
主要结局
Rate of vision adaptation to low light after blueberry juice and placebo ingestion for 3 weeks (S2).
时间窗: Pre-intervention, and changes after 3 weeks of intervention, and again after 3 weeks of washout
Effect of blueberry products and placebo on the rate of vision adaptation to low light. The rate of vision adaptation is measured by lowest perceptible light intensity after 30 min of darkness (dark threshold); time to reach dark threshold (min); time to reach rod/cone transition (min) \[Time Frame: Pre-intervention, after 3 weeks intervention, again after a 3 week washout.\] \[Designated as safety issue: No\]
Rate of vision adaptation to low light after ingestion of blueberry juice and placebo for 12 weeks (L1).
时间窗: Preintervention, and changes after 8 and 12 weeks of intervention and after 4 and 8 weeks of washout
Effect of blueberry products and placebo on the rate of vision adaptation to low light. The rate of vision adaptation is measured by lowest perceptible light intensity after 30 min of darkness (dark threshold); time to reach dark threshold (min); time to reach rod/cone transition (min) \[Time Frame: Pre-intervention, after 8 and 12 weeks intervention, and again after 4 and 8 weeks washout\] \[Designated as safety issue: No\]
次要结局
- Rate of recovery of visual acuity after retinal photostress (S2).(Pre-intervention testing and testing for changes after 3 weeks of intervention and 3 weeks of washout)
- Rate of recovery of visual acquity after retinal photostress (L1).(Pre-intervention and then testing for changes after 8 and 12 weeks of intervention and 4 and 8 weeks of washout.)
研究者
Wilhelmina Kalt
Scientist
Atlantic Food and Horticulture Research Center