Estimation of Daily Optimal Efficacy Dose (OED) of Jarlsberg Cheese in Order to Increase the Osteocalcin Level in Young, Active Norwegian Cross-country Skiers (XCS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Meddoc
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- tOC
研究概览
简要总结
The main aim was to estimate the daily OED of Jarlsberg cheese related to increased total serum Osteocalcin (tOC) level in young, active female and male Cross-country skiers (XCS).
The study population consists of active Cross-country Skiers (XCS) of both genders above 18 years of age.
The optimal daily intake of Jarlsberg cheese is assumed to have a dose window of [20 - 100] gram/day and a starting dose of 47 gram/day for both female and male.
The study was performed equally as an open, two-armed within-patient Response Surface Pathway (RSP) trial with three design level and skewed starting dose.
The main response variable will be the change in the tOC level after four weeks from baseline of the given design level.
Participants, who fulfil 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. All demographic data, social factors, history of disease and vital signs will be recorded at screening.
Blood samples was taken at screening and every four weeks. Muscle strength, Peak VO2 and BMD recorded at screening and at the end of the clinical part week12.
Ten female and 10 male XCS divided was be included, perform and completed the study.
详细描述
Aim
- To estimate the daily OED of Jarlsberg cheese related to increased total serum Osteocalcin (tOC) level in young, active female and male Cross-country skiers (XCS).
- To estimate the effect of daily Jarlsberg cheese intake on increased, muscle strength, peak VO2 and bone mineral density.
Study population: The study population consists of active Cross-country Skiers (XCS) of both genders above 18 years of age. The study is separated in one female and one male XCS study arm.
Trial treatment:The optimal daily intake of Jarlsberg cheese is assumed to have a dose window of [20 - 100] gram/day and a starting dose of 47 gram/day for both female and male. The cheese is received in package of 250 gram divided in 16 slices of 15.625 gram. 47 gram represents 3 slices of cheese.
Design and randomization: The female and the male arms of the study will be performed equally as an open, two-armed within-patient Response Surface Pathway (RSP) study with three design level and skewed starting dose. The two parts will be performed separately in parallel with identical RSP-design.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy active XCS of both genders past the age of 18 years
排除标准
- •Eating disorder
- •Pregnancy
- •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.
- •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
tOC
时间窗: Week 12
Total serum Osteocalcin in ng/ml
次要结局
- CTX(Week 12)
- K2(Week 12)
- MS(Week 12)
- PINP(Week 12)
- BMD(Week 12)