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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female participants (non-pregnant) aged 18–45 years (both inclusive), with a body weight of at least 50 kg.
- •Participants willing to provide written informed consent and committed to adhering to study guidelines and procedures and availability throughout the study duration.
- •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.
- •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.
- •Exclusion of eggs from the diet for at least two weeks prior to dosing and during the study period.
- •Non-smokers and non-alcohol users.
- •Negative screening results for HIV-1, HIV-2, and hepatitis B infections.
- •Participants with screening laboratory values within normal reference ranges or deemed clinically insignificant by the physician or Principal Investigator.
- •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).
排除标准
- •Participants with a known allergy to XanMax 2002, lutein, zeaxanthin, or related compounds, food, or any medications.
- •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.
- •Institutionalized individuals or those unable to provide informed consent.
- •History or presence of chronic illnesses, including diabetes, hypertension, liver or kidney disorders, cardiovascular or pulmonary diseases, gastrointestinal conditions, infections, dermatological disorders, or malignancies.
- •History or presence of thyroid dysfunction (hypo or hyperthyroidism).
- •Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, unexplained anemia, dysphagia, or abdominal mass.
- •History of milk, gluten allergies or other known food intolerances and or any food allergies.
- •History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rashes.
- •History of habitual intake of high caffeine (greterthan 5 cups of coffee or tea/day).
- •History of difficulty with blood donation or accessibility of veins.
- •History of drug or alcohol dependence.
- •Blood donation exceeding 350 mL within 90 days prior to the study.
- •Participation in another clinical study within the last 90 days.
- •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.
- •Recent dehydration due to diarrhea, vomiting, or other causes within 24 hours prior to check-in.
- •Consumption of food and beverages containing xanthine (e.g., chocolates, tea, coffee or cola drinks) for at least two days prior to check in.
- •Consumption of grapefruit, sweet lime, or similar citrus fruits or juices within seven days prior to check in.
- •History of supplementation with macular carotenoids, omega 3 fatty acids, or alpha lipoic acid within 14 days before the study.
- •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.
- •Positive results for drugs of abuse (e.g., benzodiazepines, barbiturates, opioids, cannabinoids, etc.) or alcohol breath tests at check-in.
- •Female participants with a positive pregnancy test, those who are breastfeeding, or those likely to become pregnant during the study.
- •Use of implanted or injected hormonal contraceptives within six months prior to the study.
结局指标
主要结局
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
时间窗: 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
次要结局
- Incidence, severity, and relationship of adverse events (AEs).(• Changes from baseline in clinical laboratory parameters (hematology, biochemistry, and urinalysis).)
研究者
DrAmbrish C
Medstar Speciality Hospital