NCT05787808RecruitingNot Applicable
The Effect on Bone Marker and Body Mineral Density (BMD) of Daily Jarlsberg Cheese Intake in Risk Patient for Osteoporosis
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Meddoc
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Bone Mineral Density
Study Overview
Brief Summary
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.
Detailed Description
Aim
- To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese on BMD and bone markers to patients with Osteopeni (OP).
- To compare daily intake of Calsium (Ca) and vitamin D with and without OED of Jarlsberg on BMD and bone markers to OP patients.
- To compare daily intake of Ca and vitamin D with and without OED of Jarlsberg on Time-to-Osteoporotic (TTO) treatment is recommended.
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.
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 cheese will be delivered in package of 250 gram with slices of 15.625gram. 45 gram represents 3 slices; 55 gram 4 slices. All the included patients will receive 20µg vitamin D and 1000 mg Ca. Half of the patients will receive vitamin D and Ca-tablets plus Jarlsberg cheese (Treatment group I) and other half only vitamin D and Ca-tablets (Treatment group II).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Masking is not posible in this study
Eligibility Criteria
- Ages
- 55 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Osteopeni patients (OP) of both genders above 55 years of age. OPs are defined as patients with T-score below 0.0 but larger than -2.5.
Exclusion Criteria
- •• Eating disorder
- •Known gastrointestinal disorder.
- •Abnormal liver or kidney function.
- •Diabetes mellitus type I.
- •Diabetes type II without sufficient control.
- •Suffering from verified cancer.
- •Under systemic treatment with corticosteroids or other immunosuppressive drugs the last 3 weeks before start of the trial treatment.
- •Under active antiresorptive treatment or anabolic treatment.
- •Participating in another clinical trial with pharmaceuticals the last six weeks before start of this trial treatment.
- •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
Bone Mineral Density
Time Frame: Week 48
g/cm2
Secondary Outcomes
- Procollagen type 1 N-terminal propeptide (PINP)(Week 48)
- Osteocalcin(week 48)
- Bone specific ALP (BALB)(Week 48)
- Cross-linked C-telopeptide type I collagen (CTX)(week 48)
Investigators
Prof Stig Larsen
Professor Emeritus
Meddoc
Study Sites (2)
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