Beneficial Effects of Lutein on Visual Function in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Co-primary outcome: Cone Sensitivity Recovery
研究概览
简要总结
Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of interest is middle-aged men and women who have low levels of carotenoids in their eyes.
详细描述
The participants will be given a brief explanation of the study and asked to sign an informed consent form. During the screening visit, pre-study parameters will be measured in order to assess the subjects' eligibility to participate.
These include:
- Medical History
- Vital signs, Height and weight and BMI calculation
- Visual Parameters
- Blood draw for clinical chemistry and hematological safety
Intervention Period:
At baseline visual parameters and a serum sample for analysis of inflammatory markers will be taken. Supplements will be dispensed. Study visits will then be conducted every 3 months. At these visits, subjects will have visual parameters, adverse events, study diary, vitals, a questionnaire evaluating health/diet/exercise/alcohol, product distribution and compliance checked. A final serum/plasma sample will be taken at the final visit for re-assessment of safety parameters and inflammatory markers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All parties involved in the study are blinded
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women age 40-60 years
- •Corrected Visual Acuity of 20/20 to 20/25
- •MPOD 0.05- 0.30 OD units
- •Must be able to give written informed consent in English
- •BMI < or = 30 kg/m2
- •Subject is willing to maintain a habitual diet and physical activity patterns throughout the study period
排除标准
- •Use of carotenoid, fish oil, or n-3 fatty acid supplements (within 2 months of study start)
- •Ocular pathologies
- •History of active small bowel disease or resection
- •Uncontrolled hypertension
- •Diabetes mellitus
- •Pancreatic disease
- •Pregnancy (or planning to become pregnant) or lactation
- •Diseases that interfere with fat absorption
- •Medication or supplements that contain a significant level of carotenoids
- •Medications that interfere with fat absorption
- •Use of drugs suspected of interfering with metabolism of blood clotting
- •Chronic alcohol intake
- •Stroke, head injury with loss of consciousness or seizures
- •Severe Amblyopia resulting in visual acuity worse than 0.4 MAR
- •Subject is a heavy smoker (> 1 pack/day)
- •A regular consumer of lutein rich foods or lutein supplements
- •A regular consumer of foods high in DHA intake or DHA supplements
- •Subject has donated more than 300 mL of blood during the last three months prior to screening
研究组 & 干预措施
Placebo
Will be identical looking to treatment
干预措施: Placebo (Dietary Supplement)
Lutein
10 mg of FloraGLO Lutein
干预措施: Lutein (Dietary Supplement)
结局指标
主要结局
Co-primary outcome: Cone Sensitivity Recovery
时间窗: 9 months
Visual Parameter
Co-primary outcome: Chromatic Contrast Sensitivity
时间窗: 9 months
Visual Parameter
次要结局
- Plasma Carotenoid Levels(9 months)
- Visual Acuity(9 months)
- Dark Adaption(9 months)
- Macular Pigment Optical Density(9 months)
- Complement Factor D, C5a, and MAC(9 months)