Estimation of Daily Optimal Efficacy Dose (OED) of Jarlsberg Cheese to Increase the Osteocalcin Level in Healthy Norwegian Elderly Male and Female
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Meddoc
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Serum Osteocalcin level
研究概览
简要总结
Aim: To estimate OED of Jarlsberg cheese and the stabilized level of serum Osteocalcin in healthy elderly men and women.
Study population consists of healthy men at least 65 years old and healthy post-menopausal women.
Trial treatment: Daily intake of Jarlsberg cheese within a window of [20 - 100] gram/day and a starting dose of 40 gram/day Design: The study will be performed as an open, two-armed between-patient randomized Response Surface Pathway (RSP) study with three design level and skewed starting dose.
Study procedure: HVs who fulfils the inclusion criteria, do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study one week later. All demographic data, social factors and history of disease will be recorded. The design consists of three design levels and measurement taken at screening, after four weeks daily intake of the decided dose of Jarlsberg cheese. At screening, after four weeks of daily intake of Jarlsberg cheese, a physical examination ,CTCAE and concomitant medication will be performed. Additionally, blood sampling will be taken at screening and after four weeks for measurements of Osteocalcin, PINP, CTX, BALP, vitamin K and common laboratory variables.
Sample size: Fifteen female and 15 male HVs divided on 3 design levels.
详细描述
Aim: To estimate OED of Jarlsberg cheese and the stabilized level of serum Osteocalcin in healthy elderly men and women.
Study population consists of healthy men at least 65 years old and healthy post-menopausal women.
Trial treatment: Daily intake of Jarlsberg cheese within a window of [20 - 100] gram/day and a starting dose of 40 gram/day
Design: The study will be performed as an open, two-armed between-patient randomized Response Surface Pathway (RSP) study with three design level and skewed starting dose. One arm consists of healthy post-menopausal women and the other of healthy men at least the age of 65years. The two arms will be performed separately in parallel with identical RSP-design.
The aim is to estimate OED based on percent change in the Osteocalcin level from baseline to 4 weeks of daily intake of Jarlsberg cheese. The main outcome variable will be categorized in the following four categories:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
Jarlsberg cheese
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy post-menopausal women and men passed the age of 65years
排除标准
- •- Known gastrointestinal disorder
- •Abnormal liver or kidney function.
- •Suffering from verified cancer
- •Under systemic treatment with corticosteroids or other immunosuppressive drugs the last 3 weeks before start of the trial treatment.
- •LDL-cholesterol > 3 mmol/L or Triglyceride > 2 mmol/l
- •Participating in another clinical trial with pharmaceuticals the last six weeks before start of this trial treatment.
- •Lactose intolerance or known milk product allergy
- •Not able to understand information.
- •Do not want or not able to give written consent to participate in the study.
结局指标
主要结局
Serum Osteocalcin level
时间窗: Week 4
tOC
次要结局
- CTX(Week 4)
- PINP(Week 4)