The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - A Randomized Controlled Cross-over Meal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Serum Ionized calcium concentration
研究概览
简要总结
This is a randomized controlled cross-over meal study with the overall aim to investigate the postprandial calcium absorption from calcium permeate compared with calcium carbonate. The hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium carbonate. This will be investigated in a cross-over design with 10 postmenopausal women age 50-65 as subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is >50 years and <65 years of age by the time of inclusion.
- •Subject has been menopausal for 2-5 years.
- •Subject willing and able to meet at University Hospital, Køge for three whole days in one month.
- •Subject is non-smoking or able not to smoke during clinic visits.
- •Subject with no history of osteoporotic fractures.
- •Subject is willing and able to provide written informed consent prior to participation.
排除标准
- •Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy.
- •Subject with vitamin D insufficiency defined as ≤50nmol/l.
- •Subject with an osteoporosis diagnosis.
- •Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
- •Subject with any serious illness e.g. cancer.
- •Subject with lactose intolerance.
- •Subject with celiac disease.
- •Known or suspected abuse of alcohol or recreational drugs.
- •Known or suspected hypersensitivity to trial products or related products.
- •Subject where it is not possible to obtain sufficient data.
结局指标
主要结局
Serum Ionized calcium concentration
时间窗: 3 months
Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample will be collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).
次要结局
- Urine magnesium concentration(3 months)
- Serum magnesium concentration(3 months)
- Serum PTH concentration(3 months)
- Urinary calcium concentration(3 months)
- Serum calcium concentration(3 months)
- Serum phosphate concentration(3 months)
- Urine phosphate concentration(3 months)
研究者
Inge Tetens
Professor
University of Copenhagen