CTRI/2025/02/080477 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On:
12/02/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Nutraceutical
Study Design
Randomized, Crossover Trial
Public Title of Study
Oral Bioavailability Study of lutein and trans-zeaxanthin and combination product
Scientific Title of Study
A randomized, double-blind, crossover study to assess the comparative oral bioavailability of XanMax® 2002 (20 mg of lutein and trans-zeaxanthin in 10:1 ratio) capsule compared to XanMax® 2002 plus LuZeAbilityTM (self-emulsifier) capsule in healthy adult volunteers
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
XanMax2002/BA/2024 Version 1.0 dated 24th October 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
DrAmbrish C
Designation
Principal investigator
Affiliation
Medstar Speciality Hospital
Address
641/17/1/3, Medstar Speciality Hospital, Ground floor Room number 2
Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka
Dose : 364 mg of capsule
Frequency: single oral dose on day 0
Wash out period: 21 days
Intervention
XanMax2002 capsule
Dose : 364 mg of capsule
Frequency: single oral dose on day 0
Wash out period: 21 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Healthy male and female participants (non-pregnant) aged 18–45 years (both inclusive), with a body weight of at least 50 kg.
2. Participants willing to provide written informed consent and committed to adhering to study guidelines and procedures and availability throughout the study duration.
3. 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.
4. Adherence to dietary restrictions, including limiting intake of lutein and zeaxanthin-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, and peaches etc.) to no more than 1–2 servings per day for at least one week prior to dosing and throughout the study.
5. Exclusion of eggs from the diet for at least two weeks prior to dosing and during the study period.
6. Non-smokers and non-alcohol users.
7. Negative screening results for HIV-1, HIV-2, and hepatitis B infections.
8. Participants with screening laboratory values within normal reference ranges or deemed clinically insignificant by the physician or Principal Investigator.
9. 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. Postmenopausal for at least one year, or
c. Surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, hysterectomy).
ExclusionCriteria
Details
1. Participants with a known allergy to XanMax 2002, lutein, zeaxanthin, or related compounds, food, or any medications.
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 (greterthan 5 cups of coffee or tea/day).
10. History of difficulty with blood donation or accessibility of veins.
11. History of drug or alcohol dependence.
12. Blood donation exceeding 350 mL within 90 days prior to the study.
13. Participation in another clinical study within the last 90 days.
14. 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, beta carotene, lycopene, or beta cryptoxanthin or other carotenoids) within 30 days before screening.
15. Recent dehydration due to diarrhea, vomiting, or other causes within 24 hours prior to check-in.
16. Unusual dietary patterns (e.g., fasting for religious reasons) within 48 hours prior to check in.
17. Consumption of food and beverages containing xanthine (e.g., chocolates, tea, coffee or cola drinks) for at least two days prior to check in.
18. Consumption of grapefruit, sweet lime, or similar citrus fruits or juices within seven days prior to check in.
19. History of supplementation with macular carotenoids, omega 3 fatty acids, or alpha lipoic acid within 14 days before the study.
20. 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.
21. Positive results for drugs of abuse (e.g., benzodiazepines, barbiturates, opioids, cannabinoids, etc.) or alcohol breath tests at check-in.
22. Female participants with a positive pregnancy test, those who are breastfeeding, or those likely to become pregnant during the study.
23. Use of implanted or injected hormonal contraceptives within six months prior to the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Case Record Numbers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Pharmacokinetic parameters of XanMax® 2002 (20 mg of lutein and trans-zeaxanthin in a 10:1 ratio) capsule compared to XanMax® 2002 plus LuZeAbilityTM (self-emulsifier) capsule
Single venous blood sample will be withdrawn at 0.00 hours 0.5 hours, 1.00 hour 2.00 hours, 4.00 hours, 8.00 hours , 12.00 hours , 24.00 hours , 48.00 hours, and 72.00 hours
Secondary Outcome
Outcome
TimePoints
Incidence, severity, and relationship of adverse events (AEs).
• Changes from baseline in clinical laboratory parameters (hematology, biochemistry, and urinalysis).
• Changes in vital signs (heart rate, blood pressure, respiratory rate, and body temperature).
• Findings from physical examinations (PEs).
Screening to end of the study of study Period 2 including 21 days wash out period
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "24" Final Enrollment numbers achieved (India)="24"
Phase of Trial
N/A
Date of First Enrollment (India)
24/02/2025
Date of Study Completion (India)
18/03/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="2" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
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
Despite its proven effectiveness, the bioavailability of lutein and zeaxanthin can be further optimized through advanced formulation techniques. A novel XanMax® 2002 capsule with LuZeAbilityTM(self-emulsifier) has been developed to maximize carotenoid absorption, leveraging the benefits of emulsification to enhance solubility and bioavailability. By forming fine emulsions in the GI tract, the self-emulsifier enhances the uptake of these carotenoids, ensuring better bioavailability and efficacy in promoting eye and overall health.This randomized, double-blind, crossover study aims to compare the oral bioavailability of the standard XanMax® 2002 (20 mg of lutein and trans-zeaxanthin in a 10:1 ratio) capsule with XanMax® 2002 plus LuZeAbilityTM(self-emulsifier) capsule in healthy adult volunteers. By directly comparing these two formulations, the study seeks to determine whether the self-emulsifying system provides a significant advantage in delivering lutein and zeaxanthin to support eye health and healthy aging—this investigation being critical in the context of addressing the widespread need for effective, bioavailable carotenoid supplementation. The findings will provide valuable insights into the comparative efficacy of these formulations, contributing to the development of enhanced nutritional strategies for vision care and overall health. The present study is therefore designed to assess the comparative bioavailability of the two investigational products with the study title—“A randomized, double-blind, crossover study to assess the comparative oral bioavailability of XanMax® 2002 (20 mg of lutein and trans-zeaxanthin in 10:1 ratio) capsule compared to XanMax® 2002 plus LuZeAbilityTM (self-emulsifier) capsule in healthy adult volunteers