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CTRI Number  CTRI/2025/11/097077 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical Study on Lutein and Zeaxanthin 164 for Better Eye Health. 
Scientific Title of Study   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 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/MPOD2/2025 Version Number: 1.0 Date: 23rd Jul 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mousumi Banerjee  
Designation  Principal Investigator  
Affiliation  Narayana Nethralaya Eye hospital 
Address  Department of Ophthalmology Ground floor Room number 2 258/A Bommasandra, Hosur Rd, Electronic City, Bengaluru, Karnataka, India

Bangalore
KARNATAKA
560099
India 
Phone  9643466894  
Fax    
Email  banerjeemou12@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi  
Designation  CEO 
Affiliation  Radiant Research Services Pvt Ltd 
Address  Radiant Research Services Pvt Ltd. Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru- 560058,Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Ashok Godavarthi  
Designation  CEO 
Affiliation  Radiant Research Services Pvt Ltd 
Address  Radiant Research Services Pvt Ltd. Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru- 560058,Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com   
 
Source of Monetary or Material Support  
Nutrione 21~23F, Olympic-ro, 35da-gil, Songpa-gu, Seoul, Republic of Korea  
 
Primary Sponsor  
Name  M/s. Nutrione 
Address  21~23F, Olympic-ro, 35da-gil, Songpa-gu, Seoul, Republic of Korea  
Type of Sponsor  Other [Nutraceutical supplement company] 
 
Details of Secondary Sponsor  
Name  Address 
Botanic Healthcare Pvt Ltd   TSIIC Industrial Development Area, Plot-16/1/12 and 13 Nacharam(V), Uppal(M), Hyderabad,Telangana 500076, India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mousumi Banerjee  Narayana Nethralaya Eye hospital  Department of Ophthalmology Ground floor Room number 2 258/A Bommasandra, Hosur Rd, Electronic City, Bengaluru, Karnataka 560099
Bangalore
KARNATAKA 		 9643466894

banerjeemou12@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Nethralaya Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lutein and Zeaxanthin 20 mg   Dose :500mg,Doasge form:Capusle, Duration 90 days, 1 capsule per day in the morning with breakfast.  
Intervention  Lutein and Zeaxanthin 40 mg  Dose :500mg,Doasge form:Capusle, Duration 90 days, 1 capsule per day in the morning with breakfast 
Comparator Agent  Placebo   Dose :500mg,Doasge form:Capusle, Duration 90 days, 1 capsule per day in the morning with breakfast 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Volunteers of either sex between 40 to 85 years of age
2. Volunteers with a BMI 25 to 33 Kg per m2
3. Amenorrhea for more than 2 years
4. Volunteers with MPOD level between 0.2 to 0.4
5. Volunteers with; Wet AMD: Exudative AMD in at least one eye; Dry AMD: From early to intermediate stages
6. Able to abide the dietary regime mentioned in the protocol
7. Willing to come for regular follow up visits
8. Able to give written informed consent willingness to take part in study and able to attend all scheduled visits 
 
ExclusionCriteria 
Details  1. Hyperlipidemia greater than 6.2 mmol per L
2. People with other ophthalmic diseases besides AMD,those undergoing retinal surgery or retinal laser treatment
3. People with macular atrophy
4. People with signs of exudative changes including subretinal fluid, pigment epithelial detachment or hemorrhage in the retina
5. People with Myopia greater than 6 diopters
6. People with cataracts or corneal opacities
7. People with uncontrolled hypertension SBP greater than 140mmHg or DBP greater than 90mmHg
8.People with uncontrolled diabetes HbA1C greater than 7.0 percent
9. People with Rheumatoid arthritis.
10. Pregnant women or those preparing for pregnancy
11. Breastfeeding women
12. Drug addicts
13. People taking medications or controlled diet for Hyperlipidemia
14. Those undergoing hormone replacement therapy
15. People who regularly take supplements or health functional foods
16. People who regularly use eye drops
17. 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
18. Heavy smokers greater than or equal to 20 cigarettes per day
19. Contact lens wearers: those who wear lenses for more than 3 days a week
20. People with allergies or adverse reactions to the test substances
21. People who have taken health functional foods related to the corresponding functionality within 3 months prior to the start of the trial
22. People who have participated in other clinical trials within the last 3 months
23. Those deemed unsuitable for the experiment by the researcher  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome:
1. Changes in MPOD levels (Screening visit,Day 0, Day 45, Day 90)
2. Changes in contrast enhancement measurements
3. Changes in Lutein and Zeaxanthin plasma concentrations 		 Day 0, Day 45, Day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome
1. To assess the safety of Lutein Zeaxanthin 164 through Safety assessments like, hematology, and biochemistry (LFT and RFT) (Screening visit ,Day 90)
2. To measure improvement in extending visual Field test using Humphrey visual field analyzer
3. Changes in glare disability 		 Day 0, Day 45, Day 90. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   17/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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