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.
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
研究概览
简要总结
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.
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
- •Male and non-pregnant female subjects, age in the range of 18 to 45 years (both inclusive).
- •Body weight of at least 50 kgs.
- •Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and axillary temperature).
- •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.
- •Participants with screening laboratory values within normal reference ranges or deemed clinically insignificant by the physician or Principal Investigator.
- •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.
- •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.
- •Exclusion of eggs from the diet for at least two weeks prior to dosing and during the study period.
- •Negative screening results for HIV-1, HIV-2, and hepatitis B infections.
- •Adherence to fluid and posture restrictions during the in-house.
- •No history of significant alcoholism.
- •Subjects who are able to communicate effectively.
- •No history of drug abuse for the last 6 months.
- •Non-alcoholics and non-smokers will be included.
- •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).
排除标准
- •Known history of hypersensitivity to the study products (Lutein, Zeaxanthin, Astaxanthin or related compounds, food or any medication.
- •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 ( greater than5 cups of coffee or tea/day).
- •History of difficulty with blood donation or accessibility of veins.
- •Any contraindications to blood sampling
- •History of drug or alcohol dependence.
- •History of difficulty in swallowing oral solids such as Tablets, Capsules etc.,
- •Blood donation exceeding 350 mL within 90 days prior to the study.
- •Participation in another clinical study within the last 90 days of the start of the study.
- •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.
- •Recent dehydration due to diarrhea, vomiting, or other causes within 24 hours prior to check-in.
- •Unusual dietary patterns (e.g., fasting for religious reasons) within 48 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.
研究者
DR AMBRISH C
Medstar Speciality Hospital