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Estimation of a Maintaining Daily Jarlsberg Cheese-dose

NCT04188080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-06-30

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Jarlsberg Cheese

Oral daily intake of Jarlsberg cheese

Sponsors & Collaborators

  • Tine

    collaborator INDUSTRY

  • Norwegian University of Life Sciences

    collaborator OTHER

  • Meddoc

    lead OTHER

Principal Investigators

  • Helge E Lundberg, MD · Skjetten Medical Center

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2020-06-05
Completion
2021-07-16

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188080 on ClinicalTrials.gov