Clinical trial · Interventional
Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese
Estimation of Minimum Efficacy Daily Dose (MTDD) of Jarlsberg Cheese in Healthy Women in Order to Obtain Needed Level of Osteocalcin: A Phase I Dose-finding Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aim: To estimate an oral administered recommended minimum efficacy daily dose (MED) of Jarlsberg cheese in order to obtain the needed increased level of Osteocalcin defined as the ratio \[Carboxylated / Under Carboxylated\] Osteocalcin. Study population: Healthy Voluntary (HV) women between 20 years and pre-menopausal age. Design: Open and randomised two-dimensional single-centre trial with 3-level between-patient Response Surface Pathway (RSP) design in the first dimension and 3-level within-patient RSP design in the secondary dimension.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes | — | UNRESOLVED | — |
| Exlution Criteria: Gastrointestinal Disorder | — | UNRESOLVED | — |
| Heathy Women | — | UNRESOLVED | — |
| Kidney Disorder | — | UNRESOLVED | — |
| Liver Disease | — | UNRESOLVED | — |
| Pre Menopausal Age | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Jarlsberg cheese | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- First design level
- description
- Three Healthy Voluntary (HV) women were give the same starting daily dose of 100 g Jarlsberg
- interventionNames
- Dietary Supplement: Jarlsberg cheese
- type
- EXPERIMENTAL
- label
- Second design level
- description
- Based on the results from the starting dose 5 + 5 HV get a new daily doses of Jarlsberg cheese
- interventionNames
- Dietary Supplement: Jarlsberg cheese
- type
- EXPERIMENTAL
- label
- Third design level
- description
- Based on the results from the second design level, the daily dose of Jarlsberg cheese for the next 7 HVs was given
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy voluntary between 20 years and pre-menopausal age Exclusion Criteria: * 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
References
Publications (0)
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