ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 3
- 主要终点
- The change in bone turnover marker CTX.
研究概览
简要总结
The primary objective of this study is to investigate the effects of 12-months supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on changes in markers of bone formation and resorption and in bone mass density (BMD) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation.
详细描述
The study will include an information visit, a randomization visit, a month 3 visit and a final visit at month 12. Besides, two visits at month 6 and 9 for dispensing of trial products. Outcome parameters will be measured using blood samples obtained at the randomization visit, the month 3 visit and at the final visit at month 12. Outcome parameters will moreover be analyzed based on DXA scan obtained at the randomization visit and at the final visit at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is between 45 years and 65 years of age by the time of inclusion.
- •Subject has been menopausal for at least 1 year, defined as 12 months after last bleeding and up to 10 years.
- •Subject is Caucasian.
- •Has a BMI below 35.
- •Holder of a computer.
- •Has a sufficient vitamin D status (plasma 25OHD concentration > 50 nmol/L).
- •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 evaluated by the investigator.
- •Intake of antibiotics in the last 3 months before enrollment.
- •Subject with an osteoporosis diagnosis or history of osteoporotic fractures.
- •Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
- •Subject with any serious illness or history of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer).
- •Known or suspected abuse of alcohol or recreational drugs.
- •Known milk allergy.
- •Known or suspected hypersensitivity to trial products or related products.
- •Blood donation except from the donation in this study.
- •Subject where it is not possible to obtain sufficient data.
结局指标
主要结局
The change in bone turnover marker CTX.
时间窗: 1 year
Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit)
The change in bone turnover marker P1NP.
时间窗: 1 year
Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit)
The change in loss of bone mineral density.
时间窗: 1 year
Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit)
次要结局
- Changes in blood parameters of iPTH(1 year)
- Changes in blood parameters of Vitamin D(1 year)
- Changes in blood parameters of phosphate(1 year)
- Changes in blood parameters of total calcium(1 year)
研究者
Inge Tetens
Professor
University of Copenhagen