The Effects of a Zeaxanthin Intervention on Visuomotor Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Macular pigment optical density
研究概览
简要总结
This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).
详细描述
This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: ≥18 and ≤ 40 years
- •BMI: ≥ 20 and ≤ 30 kg/m2
- •No anticipated changes in dieting habits (as relevant to the intake of xanthophylls and fats/oils).
- •No anticipated surgical procedures.
- •Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
- •Corrected visual acuity (ETDRS): better than 20/60 in the eye selected for the study
排除标准
- •Current or history of relevant ocular diseases (such as AMD) or other conditions e.g., lipid disorders.
- •Inability to reliably perform macular pigment optical density measurements by "Heterochromatic Flicker Photometry" or any of the other ophthalmic tests of the study.
- •Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls (e.g., digestive disorders: inflammatory bowel disease, ulcerative colitis, Crohn's, irritable bowel, etc. or lipid disorders including conditions such as hypercholesterolemia)
- •Current use of xanthophyll containing supplements or use of xanthophyll containing supplements in the past 6 months (but excluding multivitamins containing lutein or zeaxanthin at low potency).
- •Participation in any other study during last 1 month before study initiation.
- •Known hypersensitivity or allergy to xanthophylls.
- •Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes. These include diabetes medication and statins or any other drug/supplement to modulate cholesterol or fat digestion/absorption.
研究组 & 干预措施
combinatory supplement
placebo combinatory supplement
干预措施: combinatory supplement (Dietary Supplement)
zeaxanthin
placebo zeaxanthin
干预措施: zeaxanthin (Dietary Supplement)
结局指标
主要结局
Macular pigment optical density
时间窗: one year
Increases in the amount of macular pigment measured in optical density units
次要结局
- fixed reaction time(one year)
- variable reaction time(12-months)
- coincidence anticipation(12-months)
研究者
Billy R. Hammond
Professor and Principal Investigator
University of Georgia