Effect of Coca-Cola on Iron Absorption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Non-haem iron absorption
研究概览
简要总结
The aim of this project is to measure the effect of Coca-Cola and Diet Coke, relative to mineral water, on non-haem iron absorption. The results from this study will quantify any enhancing effect of Coca-Cola or Diet Coke on non-haem iron absorption and will be of use to the Coca-Cola Company and the scientific and nutrition community in evaluating the nutritional value of these products.
详细描述
Previous studies have suggested that Coca-Cola may enhance absorption of non-haem iron. A randomized cross-over trial will be undertaken to compare the absorption of iron added to a pizza meal consumed with either Coca-Cola, Diet Coke or mineral water. Pizza containing added iron, labelled with an iron stable isotope (Fe-58), will be consumed for lunch on two consecutive days with either a Coca-Cola, Diet Coke or mineral water drink. Iron absorption from the pizza will be determined using the erythrocyte incorporation technique.
A baseline blood sample will be taken prior to consuming the first test meal (pizza + drink 1) and after approximately 15 days, a second fasting blood sample will be taken prior to consumption of a second set of test meals (pizza + drink 2). Iron isotope enrichment of the blood sample will be used as a baseline for the second set of test meals and to calculate absorption from the first set of test meals. A third blood sample will be taken after approximately 30 days and the iron isotope enrichment will be used as a baseline for the third set of test meals (pizza + drink 3) and to determine absorption from the second set of test meals. At about 45 days a final blood sample will be taken to determine absorption from the third set of test meals. Iron absorption will be calculated from the isotopic enrichment in blood, assuming that 80% of absorbed iron is incorporated into red blood cells. Absorption of iron consumed with Coca-Cola and Diet Coke will be compared with iron absorption when consumed with mineral water. The order in which the volunteers will be given the drinks will be randomised.
研究设计
- 研究类型
- Interventional
- 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > 18 and < 65
排除标准
- •Age < 18 or > 65
- •BMI <18.5 or > 35
- •Serum ferritin value of <12 or >50µg/L (±10% to allow for day to day and analytical variation)
- •Volunteers will be excluded if they are found to have depressed or elevated blood pressure measurements (<90/50 or <95/55 if symptomatic or >160/100)
- •Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease.
- •Gastrointestinal disease (excluding hiatus hernia unless symptomatic or study intervention/procedure is contraindicated)
- •Regular prescribed medication that may interfere with iron metabolism
- •Regular use of antacids and laxatives (at least once a week)
- •Women who are pregnant or less than 12 months since giving birth
- •Women breast feeding
- •Vitamin supplements with or without minerals if taken more than once a week, and unwillingness to discontinue occasional use for the duration of study
- •Unwillingness to discontinue use of herbal supplements for the duration of study
- •Use of antibiotics within four weeks prior to study start
- •Parallel participation in another study which involves dietary interventions or sampling of blood that may increase the volume taken above 500ml in a 4-month period
- •Asthma requiring treatment within the last two years
- •Results of clinical screening which indicate, or are judged by the HNU Medical Advisor to be indicative of a health problem which could compromise the well-being of the volunteer if they participated or which would affect the study data.
- •Allergy to any of the ingredients in the test meals
结局指标
主要结局
Non-haem iron absorption
时间窗: 1 year
次要结局
未报告次要终点