CTRI/2025/11/098147 [Registered on: 27/11/2025] Trial Registered Prospectively
Last Modified On:
07/01/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioavailability study of lutein, zeaxanthin, and astaxanthin combination in healthy subjects
Scientific Title of Study
A Randomized, Double-Blind, Crossover Study to Assess the Comparative Bioavailability of a Lutein, Zeaxanthin, and Astaxanthin Complex with LuZeAbility™ Capsule in Healthy
Adult Volunteers.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
DH-BA_10/2025 Version Number: 1.0 Date: 15 Oct 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
DR AMBRISH C
Designation
Principal Investigator
Affiliation
Medstar Speciality Hospital
Address
641/17/1/3, Kodigehalli Main Road Ground floor Room number 2
Shanthivana, Sahakarnagar, Bengaluru-560 092, Karnataka, India
Bangalore KARNATAKA 560092 India
Phone
9845895911
Fax
Email
drambrishmedstar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Shubarani M
Designation
Head Medical Services
Affiliation
Bangalore Clinical Services
Address
Novel Tech Park
#46/4, Hosur Road, Kudlu Gate
Bengaluru-560 068
Karnataka, India.
Bangalore KARNATAKA 560068 India
Phone
09449453674
Fax
Email
clinical@bangaloreclinicalservices.com
Details of Contact Person Public Query
Name
Dr Shubarani M
Designation
Head Medical Services
Affiliation
Bangalore Clinical Services
Address
Novel Tech Park
#46/4, Hosur Road, Kudlu Gate
Bengaluru-560 068
Karnataka, India.
Bangalore KARNATAKA 560068 India
Phone
09449453674
Fax
Email
clinical@bangaloreclinicalservices.com
Source of Monetary or Material Support
DAEHAN CHEMTECH CO., LTD.
B-1208, 65, Gwacheon-daero 7-gil
Gwacheon-si, Gyeonggi-do 13840, South Korea
Primary Sponsor
Name
DAEHAN CHEMTECH CO., LTD.
Address
B-1208, 65, Gwacheon-daero 7-gil
Gwacheon-si, Gyeonggi-do 13840, South Korea
Type of Sponsor
Other [Nutraceutical Supplement Company]
Details of Secondary Sponsor
Name
Address
NIL
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
DR AMBRISH C
Medstar Speciality Hospital
Room No 02, Department of General medicine, 641/17/1/3, Kodigehalli Main Road
Shanthivana, Sahakarnagar, Bengaluru-560 092, Karnataka, India Bangalore KARNATAKA
1. Male and non-pregnant female subjects, age in the range of 18 to 45 years (both inclusive).
2. Body weight of at least 50 kgs.
3. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature).
4. Participants with no evidence of underlying medical conditions as determined by medical history, physical examination,
electrocardiogram (ECG), chest X-ray (posteroanterior view),and laboratory investigations performed within 7 days prior to
study initiation.
5. Participants with screening laboratory values within normal reference ranges or deemed clinically insignificant by the
physician or Principal Investigator.
6. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages
(chocolates, tea, coffee or cola drinks) or grapefruit juice and tobacco products for 48 hours prior to dosing until after the last
blood sample collection in the study.
7. Adherence to dietary restrictions, including limiting intake of lutein, zeaxanthin, and astaxanthin-rich foods (e.g., mangoes,
tangerines, oranges, asparagus, broccoli, butternut squash, cilantro, collards, orange pepper, parsley, papaya, peas, pistachio,
romaine lettuce, scallions, zucchini, kale, brassica oleracea, spinach, carrots, corn, tomatoes, nectarines, peaches, salmon,
shrimp, and lobster etc.) to no more than 1–2 servings per day for at least one week prior to dosing and throughout the study.
8. Exclusion of eggs from the diet for at least two weeks prior to dosing and during the study period.
9. Negative screening results for HIV-1, HIV-2, and hepatitis B infections.
10. Adherence to fluid and posture restrictions during the in-house.
11. No history of significant alcoholism.
12. Subjects who are able to communicate effectively.
13. No history of drug abuse for the last 6 months.
14. Non-alcoholics and non-smokers will be included.
15. Female participants must meet one of the following criteria.
a) Practicing a reliable method of contraception (e.g., condoms,
diaphragm, IUD) throughout the study or
b) Post- menopausal for at least one year or
c) Surgically sterile (e.g., bilateral tubal ligation, bilateral
oophorectomy, hysterectomy).
ExclusionCriteria
Details
1. Known history of hypersensitivity to the study products (Lutein, Zeaxanthin, Astaxanthin or related compounds, food or any
medication.
2. Participants with resting blood pressure outside the range of 90/60 mmHg to 140/90 mmHg or a resting pulse rate below 50 beats per minute (bpm) or above 100 bpm.
3. Institutionalized individuals or those unable to provide informed consent.
4. History or presence of chronic illnesses, including diabetes, hypertension, liver or kidney disorders, cardiovascular or
pulmonary diseases, gastrointestinal conditions, infections, dermatological disorders, or malignancies.
5. History or presence of thyroid dysfunction (hypo- or hyperthyroidism).
6. Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, unexplained
anemia, dysphagia, or abdominal mass.
7. History of milk, gluten allergies or other known food intolerances and or any food allergies.
8. History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rashes.
9. History of habitual intake of high caffeine ( greater than5 cups of coffee or tea/day).
10. History of difficulty with blood donation or accessibility of veins.
11. Any contraindications to blood sampling
12. History of drug or alcohol dependence.
13. History of difficulty in swallowing oral solids such as Tablets, Capsules etc.,
14. Blood donation exceeding 350 mL within 90 days prior to the study.
15. Participation in another clinical study within the last 90 days of the start of the study.
16. Use of any prescription or over-the-counter medications (e.g., cold or antacid preparations), enzyme-modifying drugs, or
vitamin or multivitamin supplements providing carotenoids (e.g., multivitamins, lutein/zeaxanthin, astaxanthin, beta-carotene,
lycopene, or beta-cryptoxanthin or other carotenoids) within 30 days before screening.
17. Recent dehydration due to diarrhea, vomiting, or other causes within 24 hours prior to check-in.
18. Unusual dietary patterns (e.g., fasting for religious reasons) within 48 hours prior to check-in.
19. Consumption of food and beverages containing xanthine (e.g., chocolates, tea, coffee or cola drinks) for at least two days prior to check-in.
20. Consumption of grapefruit, sweet lime, or similar citrus fruits or juices within seven days prior to check-in.
21. History of supplementation with macular carotenoids, omega-3 fatty acids, or alpha-lipoic acid within 14 days before the study.
22. History of use of enzyme inducers (e.g., rifampicin, phenobarbitone, etc.) or enzyme inhibitors (e.g. erythromycin,
fluconazole, etc.) within the last 14 days prior to check-in.
23. Positive results for drugs of abuse (e.g., benzodiazepines, barbiturates, opioids, cannabinoids, etc.) or alcohol breath tests at check-in.
24. Female participants with a positive pregnancy test, those who are breastfeeding, or those likely to become pregnant during the study.
25. Use of implanted or injected hormonal contraceptives within six months prior to the study.
Incidence, severity, and relationship of adverse events (AEs).
Changes in vital signs (heart rate, blood pressure, respiratory rate, and
body temperature).
Findings from physical examinations (PEs).
Timepoints:0 hour, 6 hours, 9 hours, 14 hours 26 hours, 36 hours, 48 hours and 72 hours post dosing of IP
Changes from baseline in clinical laboratory parameters (hematology,
biochemistry, and urinalysis).
Timepoints: Day 0, Day 4
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Beyond their protective effects against specific ocular diseases, these carotenoids contribute to overall eye health and visual performance. Lutein, zeaxanthin, and astaxanthin enhance macular pigment optical density (MPOD), which improves contrast sensitivity, visual acuity, and tolerance to glare. Regular supplementation has been shown to significantly increase MPOD, leading to better visual outcomes and protection against light-induced oxidative damage.Beyond vision, these carotenoids also offer skin health benefits. Lutein, zeaxanthin, and astaxanthin exhibit strong antioxidant and photoprotective properties, safeguarding skin cells from ultraviolet (UV)-induced oxidative damage. Supplementation has been shown to enhance skin hydration, elasticity, and resilience while reducing signs of photoaging.Given the increasing exposure to blue light from digital devices and sunlight, the combined supplementation of lutein, zeaxanthin, and astaxanthin offers a comprehensive strategy for protecting the eyes and skin from oxidative and phototoxic stress. Their synergistic antioxidant and light-filtering effects make them indispensable for maintaining ocular health, visual performance, and overall well-being.Despite its proven effectiveness, the bioavailability of lutein, zeaxanthin and Astaxanthin can
be further optimized through advanced formulation techniques. A novel capsule Lutein 18.18
mg / Zeaxanthin 1.82 mg / Astaxanthin 12 mg with LuZeAbility™ has been developed. This
study aims to evaluate bioavailability in comparison with Lutein 18.18 mg
/Zeaxanthin 1.82 mg / Astaxanthin 12 mg. This could provide insights on carotenoid
absorption, and to characterize the pharmacokinetic profile of the Test and Reference product.
This randomized, crossover study aims to compare the oral bioavailability of Lutein 18.18
mg / Zeaxanthin 1.82 mg / Astaxanthin 12 mg with LuZeAbility™ with Lutein
18.18 mg / Zeaxanthin 1.82 mg / Astaxanthin 12 mg in healthy adult human subjects.
Astaxanthin is a red-pigmented carotenoid found in various organisms such as algae, bacteria, and yeast, as well as in seafood such as salmon and crustaceans. It is known for its potent antioxidant and anti-inflammatory properties. Astaxanthin is a red fat-soluble pigment which does not have pro-Vitamin A activity in the human body, although some of the studies reported that astaxanthin has more potent biological activity than other carotenoids.Lutein and zeaxanthin are naturally occurring carotenoids primarily found in green leafy vegetables, yellow-orange fruits, and egg yolks. These compounds belong to the xanthophyll subclass of carotenoids and are distinguished by their unique chemical structure that includes hydroxyl groups, conferring both hydrophobic and antioxidant properties. Lutein and zeaxanthin are selectively concentrated in the macula of the retina, where they constitute macular pigment and are crucial for maintaining ocular health.Their deposition in the macula is hypothesized to be influenced by dietary intake, genetic factors, and systemic health conditions, with evidence suggesting that they cannot be synthesized endogenously and must be obtained through the diet or supplementation.