Lutein Absorption Consumed as Supplement, Blended Food, or Wholefood Over 24-hours.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Plasma lutein concentration
研究概览
简要总结
The aim of this study is to investigate in healthy adults, 18-40 years of age, how the absorption of 5 mg of L differs between consumption as a supplement, blended foods, and whole food equivalent of blended foods.
详细描述
The absorption the macular carotenoids has shown variability between different supplements, and food sources such as egg and spinach. Investigation of the absorption of different forms of food (e.g. cooked, raw, blended) is not as well studied. Investigating the absorption of lutein from different forms of food is important to be able to prescribe lutein from forms of food that will be optimally absorbed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females 18 to 40 years.
- •Generally healthy.
- •No participant reported history of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
- •Non-smoker.
- •English language proficiency
排除标准
- •Participant reported diagnosis of serious ocular conditions (e.g. cataracts, glaucoma, diabetic retinopathy, retinitis pigmentosa, Stagardt's disease)
- •Participant reported diagnosis, or current treatment of age-related macular degeneration.
- •Participant reported diagnosis of epilepsy.
- •Participant aversion, intolerance or allergy to study foods to be consumed (spinach, ginger, lemon, apple, flaxseeds)
- •A female currently pregnant or trying to fall pregnant.
- •Current or past smoker (within last 12 months).
- •Under 18 or over 40 years of age.
- •Currently taking a lutein supplement or consuming large amounts of foods containing lutein on a regular basis (>3 days per week).
结局指标
主要结局
Plasma lutein concentration
时间窗: Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)
Area under the curve of plasma lutein concentrations between 0 and 24 hours post lutein consumption.
次要结局
- Macular pigment optical density(Study visit day 1, day 8, day 15)
- Daily dietary lutein and zeaxanthin intake(Study visit day 1, day 8, day 15)
- Plasma lutein maximum concentration(Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours))