Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Plasma Half Life of Labeled Carotenoid
研究概览
简要总结
Tomatoes contain several compounds which may be beneficial for human health and prevention of disease, although this relationship is poorly understood and very controversial. This study uses a new technology to study the absorption and metabolism of three different compounds found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We hypothesize that by studying the absorption and metabolism of these compounds, we may be able to understand how the compounds may influence health and disease processes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between ages of 21-70 years old.
- •Body mass index of between 18 and 27 kg/m2 (inclusive).
- •Eastern Cooperative Oncology Group (ECOG)performance status of O.
- •Not currently be taking carotenoid supplements
- •Have Blood Urea Nitrogen (BUN)/Creatinine (CR), liver enzymes, Complete Blood Count (CBC), and Prothrombin time (PT/PTT/INR) within normal limits.
- •Have a hemoglobin level of at least 11 g /dL at the time of randomization.
- •Voluntarily agree to participate and sign an informed consent document.
排除标准
- •Have a known allergy or intolerance to tomatoes.
- •Have a history of a nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations.
- •Have uncontrolled hyperlipidemia (total cholesterol > 200 mg/dL, LDL > 160 mg/dL and serum triglycerides > 200 mg/dL) or lipidemia that may influence carotenoid pharmacokinetics or transport.
- •Smoke tobacco products
- •Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis.
- •Are taking certain medications (prescription or over-the-counter) such as Orlistat, which interfere with dietary fat absorption.
- •Are taking complementary and alternative medications that at the discretion of the study physician Steven K. Clinton(SKC) may interfere with carotenoid absorption or metabolism.
研究组 & 干预措施
Isotopically labeled lycopene
We will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.
干预措施: Isotopically labeled lycopene, phytoene or phytofluene (Other)
Isotopically labeled phytoene
We will administer 3.2 mg isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.
干预措施: Isotopically labeled lycopene, phytoene or phytofluene (Other)
Isotopically labeled phytofluene
We will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants.
干预措施: Isotopically labeled lycopene, phytoene or phytofluene (Other)
结局指标
主要结局
Plasma Half Life of Labeled Carotenoid
时间窗: labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.
We will study the half life of isotopically labeled carotenoids.
Time of Maximal Carotenoid Concentration
时间窗: 0 to 48 hours
We will determine when the maximal carotenoid concentration is achieved in the plasma
Maximal Plasma Carotenoid Concentration
时间窗: 0 to 48 hours
We will determine the average maximal plasma carotenoid concentration in healthy volunteers
次要结局
- Carotenoid Metabolites(Up to 28 days)
研究者
Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center