A Randomized, Double-blind, Placebo-controlled, Three-arm Clinical Study to Evaluate the Modulatory Effect of Lutein Zeaxanthin 164 Supplementation on Macular Pigment Optical Density Levels, Glare Disability and Contrast Enhancement in Healthy Subjects
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
Lutein and Zeaxanthin, potent dietary antioxidants, accumulate in the retina as key components of the macular pigment (MP). These carotenoids cannot be synthesized by the human body and must be obtained from dietary sources. Among these, Tagetes erecta (commonly known as marigold) is one of the richest natural sources of both lutein and zeaxanthin, making it valuable in the maintenance of visual health and the prevention of light-induced retinal damage. The retinal carotenoids, lutein and zeaxanthin, have been extensively studied in ophthalmologic research for their role in eye protection. Macular pigment (MP) refers to a yellow-colored spot located at the centre of the retina, known as the macula. Composed primarily of two carotenoids lutein and zeaxanthin this pigment plays a vital role in protecting the macula from harmful blue light and in supporting its proper function. The macula contains the highest density of photoreceptors in the retina and is essential for central, high-resolution vision, enabling tasks such as reading, facial recognition, and perceiving fine details. Supplementation with lutein and zeaxanthin has been shown to significantly increase levels of antioxidant enzymes, owing to their potent antioxidant activity. This action helps minimize oxidative stress and protects critical retinal structures, such as photoreceptors and the retinal pigment epithelium (RPE), from damage. The beneficial effects of lutein and zeaxanthin stem from their ability to quench singlet oxygen and other reactive oxygen species (ROS) directly within the retina. In addition, by absorbing blue light, they indirectly reduce ROS formation by limiting photo-oxidative reactions, particularly those that lead to the generation of singlet oxygen. These carotenoids also offer photoprotective benefits by absorbing harmful solar radiation, and their anti-oxidative, anti-inflammatory, and antiangiogenic properties further contribute to retinal health. Collectively, these mechanisms help prevent or slow the progression of degenerative eye conditions such as age-related macular degeneration (AMD) and cataracts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteers of either sex between 40 to 85 years of age
- •Volunteers with a BMI 25 to 33 Kg per m2
- •Amenorrhea for more than 2 years
- •Volunteers with MPOD level between 0.2 to 0.4
- •Volunteers with; Wet AMD: Exudative AMD in at least one eye; Dry AMD: From early to intermediate stages
- •Able to abide the dietary regime mentioned in the protocol
- •Willing to come for regular follow up visits
- •Able to give written informed consent willingness to take part in study and able to attend all scheduled visits.
排除标准
- •Hyperlipidemia greater than 6.2 mmol per L
- •People with other ophthalmic diseases besides AMD,those undergoing retinal surgery or retinal laser treatment
- •People with macular atrophy
- •People with signs of exudative changes including subretinal fluid, pigment epithelial detachment or hemorrhage in the retina
- •People with Myopia greater than 6 diopters
- •People with uncontrolled hypertension SBP greater than 140mmHg or DBP greater than 90mmHg 8.People with uncontrolled diabetes HbA1C greater than 7.0 percent
- •People with Rheumatoid arthritis.
- •Pregnant women or those preparing for pregnancy
- •Breastfeeding women
- •Drug addicts
- •People taking medications or controlled diet for Hyperlipidemia
- •Those undergoing hormone replacement therapy
- •People who regularly take supplements or health functional foods
- •People who regularly use eye drops
- •Alcohol addicts- Men greater than or equal to 40 g per day and Women greater than or equal to 20g per day, based on WHO daily alcohol intake guidelines
- •Heavy smokers greater than or equal to 20 cigarettes per day
- •Contact lens wearers: those who wear lenses for more than 3 days a week
- •People with allergies or adverse reactions to the test substances
- •People who have taken health functional foods related to the corresponding functionality within 3 months prior to the start of the trial
- •People who have participated in other clinical trials within the last 3 months
- •Those deemed unsuitable for the experiment by the researcher.
研究者
Dr Mousumi Banerjee
Narayana Nethralaya Eye hospital