Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Serum beta-cryptoxanthin concentration area under the curve ((µmol/L)*t)
研究概览
简要总结
The purpose of this study is to determine how well the body absorbs the carotenoid beta-cryptoxanthin (BCX) from a type of corn that has been naturally bred (not genetically engineered) to contain higher amounts of BCX than traditional breeds of corn. Because this new type of corn contains higher amounts of BCX, it appears more orange in color than traditional types of corn. Understanding how well the body can absorb the BCX from the corn may help companies develop food products that may have improved nutritional quality.
详细描述
Randomized, blinded, 3 x 3 crossover intervention. Each treatment will last 12 d, followed by a 7-d wash-out period. After the washout, subjects will go back to their regular diet for two weeks before beginning the next cycle. Subjects will report to the research kitchen in the Nutritional Sciences building for their breakfast. Maize will be incorporated into two muffins. Other food choices will be yogurt and other low-fiber foods. Blood samples will be taken at baseline and days 3, 6, 9, 12, 15, and 19. Natural abundance measurements of 13-carbone to 12-carbon will be taken at baseline, day 12 and day 19. Retinol isotope dilution testing will be done at the end of the study to determine total body stores of vitamin A in the subjects. This will include the day 19 blood sample of intervention phase 3 and a final blood sample 14 days after the isotope dose administration.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 - 28 y, BMI 19 - 26 kg/m2, non-smoking, not pregnant or trying to become pregnant, and not lactating.
排除标准
- •BMI < 19 kg/m^2 or BMI > 26 kg/m^2
- •Women: pregnant or trying to become pregnant, breast-feeding
- •Weight loss greater than or equal to 10 pounds (4.5 kilograms) during the 3 months prior to recruitment
- •Actively trying to lose weight
- •Fat malabsorptive disorders
- •Inability to refrain from drinking alcohol when requested
- •Amenorrhea
- •Acute or chronic illness, including hepatitis
- •Current or previous history of anorexia or bulimia
- •History of iron deficiency anemia
- •Inability to pick up food from research facility and eat meals on site when requested
- •Planned vacation of >1 week duration during the study
- •Known scheduling conflict with the blood draws
- •Major food allergies/intolerance to ingredients used in the meals
- •Unwillingness to discontinue personal nutritional supplements/vitamins when asked to
- •Concurrent participation in other studies
- •Social circumstances that would make it difficult to consume a study food
- •Family member already enrolled in the study
结局指标
主要结局
Serum beta-cryptoxanthin concentration area under the curve ((µmol/L)*t)
时间窗: 19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase
Serum beta-cryptoxanthin concentration area under the curve calculated from samples on days 0, 3, 6, 9, 12, 15, 19 of treatment phase
次要结局
- Vitamin A total body stores (µmol vitamin A) by retinol isotope dilution(14 days and will include the final blood of phase three and another sample 14 days later)
- Vitamin A estimated total liver reserves (µmol vitamin A/g liver) by retinol isotope dilution(14 days and will include the final blood of phase three and another sample 14 days later)
- Serum zeaxanthin, lutein, and beta-carotene concentration area under the curves ((µmol/L)*t)(19 days with blood samples drawn on days 0, 3, 6, 9, 12, 15, 19 of treatment phase)
- Serum retinol carbon-13 natural abundance (δ 13C‰)(19 days and will be measured on days 0, 12, and 19)