Meddoc Research Taiwan Ltd

Aim: To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese in patients with Osteopeni (OP).
Study population: Post-menopausal women and men above 55 years of age in risk of Osteoporosis Treatment: Daily OED Jarlsberg cheese + vitamin D and Calcium tablets. Design: An open and one-armed observational study. Main variables: Bone Mineral Density (BMD), Bone turnover markers (BTMs), Osteocalcin and K2 vitameres.
Study Procedure: Prior to inclusion in this study, all the patients have undergone 32 days of daily OED intake of Jarlsberg cheese + vitamin D and caicium tablets. Thid is the baseline of this observational study. The duration of this study is 12 months with clinical examination and bloodsampling after 6 and 12 months.
Sample size: At least 16 patients will be included

The aim is to compare the daily intake of Calsium (Ca) + vitamin D with and without daily optimal efficacy dose (OED) of Jarlsberg on Bone Mineral Density (BMD) and bone markers (BM) to Osteopeni patients (OP).
The study population consists of OP-patients of post-menopausal women and men above 55 years of age. OP patients are defined as patients with a T-score below 0.0, but larger than -2.5.
The study will be performed as a randomized, single-blinded Norwegian multicentre trial with stratified semi-cross-over design with gender and site as stratification factors. The OP-patients included in the study will be allocated to one of the two treatment groups by block randomization with random block size between 2 and 6.
Women in post-menopausal age have a daily OED Jarlsberg of 45 gram and men in the same age interval have a daily OED of 55 gram.
The main response variable will be the change in Bone Mineral Density (BMD),total Osteocalcin (tOC) and different bone markers (BM).
Participants, who fulfil the inclusion criteria, do not meet any of the exclusion criteria and willing to give informed consent to participate will be included and receiving 40µg vitamin D and 500 mg Ca tablets per day, but asked not to eat Jarlsberg cheese the following week. During this week demographic data, bloodsampling for measurement of Osteocalcin and BM and diet registration will be performed.In the clinical study, all the included patients will continue with Ca+ vitamin D, but half of the patient will additionally receive daily OED of Jarlsberg cheese. After 16 weeks, all the patients will receive both Ca+vitamin D and OED of Jarlsberg for addionally 16 weeks. The total duration of the study will be 32 weeks for the patients initially allocated to Jarlsberg and 48 weeks for those allocated only to Ca+vitamin D. The patients will be investigated initially and every 16 weeks.
A total of 30 patients will be included in each of the two groups.

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.