The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia

NCT06358443 | Completed DMC

• 1 other identifier: PF-Jarlsberg/IIIB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteopenia; Osteoporosis

Keywords

Jarlsberg cheese; BMD; BTM; Osteocalcin

Outcome Measures

Primary Outcomes (3)

• Bone Mineral Density

  Bone health

  Baseline, 6 months, 12 months

• Bone Turnover Markers

  Bone health

  Baseline, 6 month, 12 months

• Osteocalcin

  Bone health

  Baseline, 6 month, 12 months

Secondary Outcomes (1)

• Vitamin K2

  Baseline, 6 month, 12 months

Study Arms (1)

Jarlsberg cheese + vitamin D and Calcium tablets

EXPERIMENTAL

All the patients will receive optimal daily efficacy dose of Jarlsberg cheese pluss vitamin D ampulles and calcium tablets in one year

Dietary Supplement: Jarlsberg cheese

Interventions

Jarlsberg cheese DIETARY_SUPPLEMENT

Jarlsberg cheese + Vitamin D ampulles + Calcium

Also known as: Vitamin D ampulles, Calcium tablets

Jarlsberg cheese + vitamin D and Calcium tablets

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Diagnosed eating disorder.
• Serious gastrointestinal disorder.
• Serious liver or kidney disease. (GFR\<29 mL/min/1,73m2)
• Diabetes mellitus type I.
• Diabetes type II without sufficient control.
• Suffering from verified cancer.
• Under systemic treatment with corticosteroids 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 except from Jarlsberg cheese .
• Known milk protein allergy.
• Not able to understand information.
• Do not want or not able to give written consent to participate in the study.

Sponsors & Collaborators

• Meddoc: lead
• Tine: collaborator

Study Sites (1)

Skjetten Medical center

Skjetten, Akershus, 2013, Norway

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Calcium

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Anne C Whist, PhD

  Tine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One armed observational study

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: June 3, 2024
• Primary Completion: October 18, 2024
• Study Completion: November 4, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)