Maintenance DoseNCT04188080
Estimation of a Maintaining Daily Jarlsberg Cheese-dose
A study testing Jarlsberg Cheese in people with Maintenance Dose and Osteocalcin, run by Meddoc at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maintenance Dose, Osteocalcin, Vitamin K Deficiency
- What is being tested?
- Jarlsberg Cheese
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 16 Jan 2020to 16 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: De-escalation of the Daily Jarlsberg Cheese-dose Related to the Osteocalcin Level in Healthy Women: Estimation of a Maintaining Daily Jarlsberg Cheese-dose
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.
Read the detailed description
The recruited HV women fulfilled the inclusion without the exclusion criteria for the study will undergo a screening clinical investigation. The participants will be asked to avoid use of other cheese than the one allocated to in the study, but eat as usual. One week later, the first clinical investigation in the study will take place including blood sampling and measurement of visual signs. The HV women verified to fulfil the criteria for participation and signed the informed consent form will be included in the study. During this first clinical investigation in the study denoted as Day 0, the participants receive a study identification number. The daily intake of cheese will be 57g/day . The trial cheese can be consumed with other food at breakfast, lunch or other meals during the day.
The participants meet for new clinical investigations every third week with measurement of visual signs and blood sampling. The first 12 HVs finalized 6 weeks with daily intake of 57 g Jarlsberg cheese obtaining an increase in the osteocalcin level from baseline ≥10% will be offered participation in this de-escalation study. The results of the osteocalcin analysis after 6 weeks will be ready within one week and the HVs continue on unchanged cheese dose. The HVs participating in this de-escalation study will be included in this part after 7 weeks. The remaining HVs will continue the Jarlsberg cheese intake as prescribed in protocol HV-Jarlsberg/III.
The de-escalation study consists of three design level each of three weeks duration. The analysis of the osteocalcin level taken after three weeks will be ready within one week later. This measurement will be the background for change in the dose for the next design level. During this first week after the three-week period, the HVs will continue on the same cheese dose until the results from the osteocalcin analysis is available.
The HVs included in this de-escalation study will receive a reduced daily dose of Jarlsberg cheese for three weeks in the first design level. The reduction in the daily Jarlsberg cheese dose will be individually calculated. Assume a given HV obtained X % increase in the osteocalcin level during the previous six weeks with a daily dose of 57g. The reduction in the daily Jarlsberg cheese dose for the first design level will be x% [(57*X)/100]. If the osteocalcin level reduces > 10% from the 6-weeks level after 3 weeks on the reduced dose, the dose will be increased for this HV on the second design level. In case the obtained change in the osteocalcin level is ± 10%, the dose will be unchanged. If the osteocalcin level increases > 10 % from the 6-week level, the cheese dose will be reduced for this HV in the second design level. The size of the dose increase or decrease from the first to the second design level depending on the change in the osteocalcin level from the 6-week level and calculated in accordance with the RSP procedure. The change in the osteocalcin level during the second design level will be the basis for calculation of the dose to be used in the third design level. The same procedure as described for the dose-change from the first to the second design level will be used. Clinical investigation and blood sampling will be performed every third week. Osteocalcin and vitamin K will be analysed every third week whereas the haematological and biochemical analysis will be performed at baseline and after 6 and 18 weeks of cheese intake.
The main variable in this study will be osteocalcin measured in serum blood and percent increase in osteocalcin from baseline. Additionally, carboxylated and under carboxylated Osteocalcin and the ratio OR = [Carboxylated / Under Carboxylated] osteocalcin in serum will be central together with the K2 variants MK-7, 8, 9, 9(4H) and vitamin K1. Triglyceride, LDL- and HDL cholesterol, vitamin D and vital signs will be secondary variables. As safety variables, haematological- and biochemical variables and adverse events (AE) will be recorded at each visit.
In accordance with the development of the RSP-procedure, 12 HVs will be included in the study and participate in all the three design levels.
- Conditions
- Maintenance Dose, Osteocalcin, Vitamin K Deficiency
- Being tested
- Jarlsberg Cheese
- Keywords
- Jarlsberg cheese
- Medical subject headings
- Vitamin K Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jarlsberg CheeseDietary supplement
Oral daily intake of Jarlsberg cheese
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Jarlsberg Cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Osteocalcin level
Osteocalcin measured as ng/ml in blood serum
Measured: 3 weeks
Secondary outcomes (1)
Vitamin K
Vitamin K measured as ng/ml in blood serum
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start16 Jan 2020
- Primary completion5 Jun 2020
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintenance DoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-patient Response Surface Pathway
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meddoc
- Sponsor type
- University, hospital or other
- Collaborators
- Tine, Norwegian University of Life Sciences
- Responsible party
- Principal investigator, Prof Stig Larsen, Meddoc
- Investigators
- Helge E Lundberg, MD, Principal investigator, Skjetten Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188080
- Sponsor's protocol ID
- HV-Jarlsberg/IB
- Status last verified
- Jun 2022
- First submitted
- 2 Dec 2019
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation of the Daily Jarlsberg Cheese-dose Related to the Osteocalcin Level in Healthy Women: Estimation of a Maintaining Daily Jarlsberg Cheese-dose
- ClinicalTrials.gov ID
- NCT04188080
- Acronym / sponsor ID
- HV-Jarlsberg/IB
- Conditions
- Maintenance Dose, Osteocalcin, Vitamin K Deficiency
- Keywords
- Jarlsberg cheese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MeddocUniversity, hospital or other
- Collaborators
- Tine, Norwegian University of Life Sciences
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The recruited HV women fulfilled the inclusion without the exclusion criteria for the study will undergo a screening clinical investigation. The participants will be asked to avoid use of other cheese than the one allocated to in the study, but eat as usual. One week later, the first clinical investigation in the study will take place including blood sampling and measurement of visual signs. The HV women verified to fulfil the criteria for participation and signed the informed consent form will be included in the study. During this first clinical investigation in the study denoted as Day 0, the participants receive a study identification number. The daily intake of cheese will be 57g/day . The trial cheese can be consumed with other food at breakfast, lunch or other meals during the day.
The participants meet for new clinical investigations every third week with measurement of visual signs and blood sampling. The first 12 HVs finalized 6 weeks with daily intake of 57 g Jarlsberg cheese obtaining an increase in the osteocalcin level from baseline ≥10% will be offered participation in this de-escalation study. The results of the osteocalcin analysis after 6 weeks will be ready within one week and the HVs continue on unchanged cheese dose. The HVs participating in this de-escalation study will be included in this part after 7 weeks. The remaining HVs will continue the Jarlsberg cheese intake as prescribed in protocol HV-Jarlsberg/III.
The de-escalation study consists of three design level each of three weeks duration. The analysis of the osteocalcin level taken after three weeks will be ready within one week later. This measurement will be the background for change in the dose for the next design level. During this first week after the three-week period, the HVs will continue on the same cheese dose until the results from the osteocalcin analysis is available.
The HVs included in this de-escalation study will receive a reduced daily dose of Jarlsberg cheese for three weeks in the first design level. The reduction in the daily Jarlsberg cheese dose will be individually calculated. Assume a given HV obtained X % increase in the osteocalcin level during the previous six weeks with a daily dose of 57g. The reduction in the daily Jarlsberg cheese dose for the first design level will be x% [(57*X)/100]. If the osteocalcin level reduces > 10% from the 6-weeks level after 3 weeks on the reduced dose, the dose will be increased for this HV on the second design level. In case the obtained change in the osteocalcin level is ± 10%, the dose will be unchanged. If the osteocalcin level increases > 10 % from the 6-week level, the cheese dose will be reduced for this HV in the second design level. The size of the dose increase or decrease from the first to the second design level depending on the change in the osteocalcin level from the 6-week level and calculated in accordance with the RSP procedure. The change in the osteocalcin level during the second design level will be the basis for calculation of the dose to be used in the third design level. The same procedure as described for the dose-change from the first to the second design level will be used. Clinical investigation and blood sampling will be performed every third week. Osteocalcin and vitamin K will be analysed every third week whereas the haematological and biochemical analysis will be performed at baseline and after 6 and 18 weeks of cheese intake.
The main variable in this study will be osteocalcin measured in serum blood and percent increase in osteocalcin from baseline. Additionally, carboxylated and under carboxylated Osteocalcin and the ratio OR = [Carboxylated / Under Carboxylated] osteocalcin in serum will be central together with the K2 variants MK-7, 8, 9, 9(4H) and vitamin K1. Triglyceride, LDL- and HDL cholesterol, vitamin D and vital signs will be secondary variables. As safety variables, haematological- and biochemical variables and adverse events (AE) will be recorded at each visit.
In accordance with the development of the RSP-procedure, 12 HVs will be included in the study and participate in all the three design levels.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-patient Response Surface Pathway
| Arm | Type | Receives |
|---|---|---|
| Jarlsberg cheese starting dose | Experimental | Dietary Supplement: Jarlsberg CheeseThe 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- Pregnant women
- Known gastrointestinal disorder
- Abnormal liver or kidney function.
- Diabetes
- Suffering from verified cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jarlsberg CheeseOral daily intake of Jarlsberg cheese | Dietary supplement | Jarlsberg cheese starting dose |
Primary outcome
Change in Osteocalcin level
Time frame: 3 weeks
Osteocalcin measured as ng/ml in blood serum
1 secondary outcome
Vitamin K
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge E Lundberg, MD principal investigator
Skjetten Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jarlsberg Cheese in people with Maintenance Dose and Osteocalcin, run by Meddoc at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Osteocalcin level (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.