Estimation of a Maintaining Daily Jarlsberg Cheese-dose

NCT04188080 | Completed DMC

• 1 other identifier: HV-Jarlsberg/IB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to estimate a maintaining daily dose of Jarlsberg cheese in healthy pre-menopausal women obtaining an increase in the osteocalcin level of at least 10% after 6 weeks on maximum efficacy dose (MED) of Jarlsberg cheese. 1.4: Population and sampling The study population consists of Healthy Voluntary (HV) women between 20 years and pre-menopausal age. The study will be performed as a one-dimensional, within-patient, 3-level Response Surface Pathway (RSP) designed trial with individually adjustment of the dose. Each design period will be 3 weeks. Only HVs obtaining an increase in the osteocalcin level ≥ 10% from baseline after 6 weeks on the MED of 57g Jarlsberg cheese daily will be offered to participate in this de-escalation study.

Conditions

Maintenance Dose; Osteocalcin; Vitamin K Deficiency

Keywords

Jarlsberg cheese

Outcome Measures

Primary Outcomes (1)

• Change in Osteocalcin level

  Osteocalcin measured as ng/ml in blood serum

  3 weeks

Secondary Outcomes (1)

• Vitamin K

  3 weeks

Other Outcomes (1)

• Lipid status (Total Cholesterol

  6 weeks

Study Arms (1)

Jarlsberg cheese starting dose

EXPERIMENTAL

The participants obtaining an Osteocalcin increase \> 10% during the previous 6 weeks intake of Jarlsberg cheese, will get a percent reduction in the daily cheese-dose equal to the increase in the Osteocalcin level

Dietary Supplement: Jarlsberg Cheese

Interventions

Jarlsberg Cheese DIETARY_SUPPLEMENT

Oral daily intake of Jarlsberg cheese

Jarlsberg cheese starting dose

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Health women (HV) from 20 years of age and pre-menopausal age obtaining an increase in the Osteocalcin Level \>10% during 6 weeks daily intake of 57 g Jarlsberg cheese.

You may not qualify if:

• Pregnant women
• Known gastrointestinal disorder
• Abnormal liver or kidney function.
• Diabetes
• 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.

Sponsors & Collaborators

• Meddoc: lead
• Tine: collaborator
• Norwegian University of Life Sciences: collaborator

Study Sites (1)

Skjetten Legesenter

Skjetten, Akershus, 2013, Norway

Location

MeSH Terms

Conditions

Vitamin K Deficiency

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Helge E Lundberg, MD

  Skjetten Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Within-patient Response Surface Pathway

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 5, 2019
• Study Start: January 16, 2020
• Primary Completion: June 5, 2020
• Study Completion: July 16, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)