NCT01730898已完成3 期
Lutein Absorption in Healthy Adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Plasma lutein
研究概览
简要总结
This study will evaluate the absorption of lutein when consumed in different oil blends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- •BMI ≥ 18 and ≤ 25 kg/m2
- •Between 18 and 45 years of age, inclusive
- •Male or a non-pregnant, non-lactating female, nulliparous or at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential. If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study):
- •Condoms, sponge, diaphragm or intrauterine device;
- •Oral or parenteral contraceptives for 3 months prior to screening visit;
- •Vasectomized partner;
- •Total abstinence from sexual intercourse.
- •If on a chronic medication, subject has been on constant dosage for at least two months prior to screening visit
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •Current smoker
- •Current chronic disease, including malabsorption or gastrointestinal disorders; hyperlipidemia; anemia; hemophilia; excessive bleeding; cystic fibrosis; kidney disease requiring dialysis; diabetes; active malignancy; wasting condition
- •Current chronic contagious, infectious disease, such as active tuberculosis, Hepatitis B or C,or HIV
- •Vegetarian, or has very selective food habits/dieting
- •Average intake of alcoholic beverages greater than 2 drinks per day
- •Medication or dietary supplement use to lower plasma lipids or affect lipid absorption or transport, including antibiotics
- •Supplement use that contains carotenoids (multi-vitamin as an example)
- •Known allergy or intolerance to any ingredient found in the study products
结局指标
主要结局
Plasma lutein
时间窗: baseline and 336 hours
adjusted area under the curve at specified postprandial timepoint
次要结局
- Plasma carotenoids(2, 4, 6, 8, 12, 24, 48, and 336 hours)
- Plasma lipid concentrations(baseline and 48 hours)
研究者
研究点 (2)
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