A Randomized, double-blind, placebo-controlled clinical study to evaluate the modulatory effect of Lutein and Zeaxanthin supplementation on Macular Pigment Optical Density (MPOD), Glare disability and photo stress in healthy subjects.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Primary Outcome:
研究概览
简要总结
Lutein Zeaxanthin 20:4 sourced from marigold scientifically known as Tagetes erecta which is the most abundant natural source of Lutein and Zeaxanthin. The flowers of the plant are used in the extraction of Lutein & Zeaxanthin using a unique extraction technique with Hexane as the solvent. It is uniformly dispersed in sunflower oil to create homogenized mixture. The product is brick red free flowing viscous paste with characteristic odour with lutein not less than 20% and Zeaxanthin not less than 4%. The product is narrow particle size distribution, which is largely responsible for its efficacy. These macular pigments protect eyes from oxidative processes when exposed to light acting as filters in that they improve vision by increasing both the Glare of objects and their background. Lutein and Zeaxanthin reduce the lipid peroxidation which leads to damage of biological membranes, resulting in ocular tissue damage and macular degeneration.
Macular pigments promote vision in a number of different ways. Blue light filtration lessens chromatic aberration, which can improve visual acuity. The supplementation is observed to elevate the levels of anti-oxidant enzymes significantly by their strong anti-oxidant effect, may reduce the oxidative damage and minimize oxidative stress. This prevents damage to the photoreceptors and retinal pigment epithelial cells. The mechanisms responsible for the action of Lutein and Zeaxanthin by actively quenching singlet oxygen and associated free radicals in the retina, they can further reduce oxidation by filtering blue light to prevent the development of reactive oxygen species, particularly singlet oxygen, in the retina. Also includes prevention of phototoxic damage by absorbing solar radiation, reduction of oxidative stress by scavenging ROS, and antioxidant, antiangiogenic, anti-inflammatory properties and naturally either help prevent or reduce the risk of progression of eye diseases like age related macular degeneration and cataracts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Volunteers of either sex, between 45 to 65 years of age.
- •2.Volunteers with MPOD level between 0.2 – 0.4 3.Volunteers having no clinically significant ocular pathological condition, but clinically non-significant problem with accommodation of the eye can be included.
- •4.Able to abide the dietary regime mentioned in the protocol 5.Willing to come for regular follow –up visits.
- •6.Able to give written informed consent Willingness to Take part in Study and able to attend all Scheduled Visits.
排除标准
- •1.Pregnant, Breastfeeding, subjects undergone any surgery and else take taken part in any clinical Trial.
- •2.Not willing to Sign the ICF or give the consent 3.Volunteers having other ocular pathologies like glaucoma, mature cataract, pan retinal degenerations etc.
- •will be excluded.
- •4.Volunteers having systemic diseases like hyper-cholesterolemia, renal disorder, liver disorder, diabetes mellitus and other debilitating diseases.
- •5.On-going treatment with herbals or allopathic ocular drugs.
- •6.History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
- •7.Any condition that in the opinion of the investigator does not justify the patient’s inclusion for the study.
结局指标
主要结局
Primary Outcome:
时间窗: Day 0, Day-45 and Day-90
1.Changes in MPOD levels
时间窗: Day 0, Day-45 and Day-90
2.Changes in glare disability
时间窗: Day 0, Day-45 and Day-90
3.Changes in Lutein and Zeaxanthin plasma concentrations
时间窗: Day 0, Day-45 and Day-90
4.Percentage Change in Photostress recovery time
时间窗: Day 0, Day-45 and Day-90
次要结局
- Secondary Outcome:(1.To assess the safety of the product through Safety assessments like, hematology, and biochemistry (LFT and RFT))
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt.Ltd
