Estimation of Daily Optimal Efficacy Dose (OED) of Jarlsberg Cheese to Increase the Osteocalcin Level in Healthy Norwegian Elderly Male and Female
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Meddoc
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Serum Osteocalcin level
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Masking Description
Jarlsberg cheese
Eligibility Criteria
- Ages
- 65 Years to 80 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy post-menopausal women and men passed the age of 65years
Exclusion Criteria
- •- 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.
Outcomes
Primary Outcomes
Serum Osteocalcin level
Time Frame: Week 4
tOC
Secondary Outcomes
- CTX(Week 4)
- PINP(Week 4)
Investigators
Prof Stig Larsen
Research Director
Meddoc