Heathy WomenNCT04185454
Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese
A study testing Jarlsberg cheese in people with Heathy Women and Pre Menopausal Age, run by Prof Stig Larsen at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heathy Women, Pre Menopausal Age, Exlution Criteria: Gastrointestinal Disorder
- What is being tested?
- Jarlsberg cheese
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2018to 15 Apr 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy voluntary between 20 years and pre-menopausal age
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: 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
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.
Read the detailed description
The recruited HV women fulfil the inclusion without the exclusion criteria for the study will undergo a clinical investigation and blood sampling. The participants will be asked to avoid use of other cheese, but eat as usually. One week later, the first clinical investigation will take place including blood sampling. The HV women verified to fulfil the criteria for participation and signed the informed consent form will be included in the study. The trial treatment consisting of a given gr/day Jarlsberg cheese will start the day after this investigation, denoted as Day 0, and the participants receiving a study identification numbers. They will be instructed not to change eating habit except replace use of other chees with Jarlsberg.
The cheese can be consumed with other food at breakfast and/or lunch. The dose of Jarlsberg cheese per day is fixed per participant and varies from 20 gram per day to 180 gram per day with a mid-dose of 100gr/day. The three patients included at the first design level will all receive this mid-dose of 100gr/day. Clinical investigation and blood sampling after start of the treatment, will be performed after 3, 4, and 5 weeks and the ratio [Carboxylated / Under Carboxylated] Osteocalcin will be calculated. This increased Osteocalcin Ratio (OR) based on the results obtained by the blood sampling at week 3 will be classified in five groups and used for determination of the Jarlsberg cheese dose for the five HV women at design level 2. The classifications of increased OR used are: increased OR < 0.5 classifies as Low; 0.5 ≤ increased OR ≤ 0.9 classifies as Moderate Low; 0.9 < increased OR < 1.1 classifies as Suitable; 1.1≤increased OR≤1.5 classifies as Moderate High; increased OR > 1.5 classifies as High. In case the increased OR is found Low or Moderate Low, the daily dose of Jarlsberg cheese will be reduced for the participants at the second design level. If increased OR classifies as Suitable the same dose as at design level 1 will be recommended applied at the second level and if increased OR classifies as moderate High or High, the Jarlsberg cheese-dose will be increased.
The same procedure based on the results obtained from the five participants at the second design level will be used to determine the daily Jarlsberg-dose for the seven HV women at design level 3. With randomization of the recommended cheese-doses at one design level to be used in the next, the between-patient Response-Surface-Pathway (RSP) design-arm is applied.
The within-patient RSP design-arm is applied and related to the duration of the cheese intake. All the participants will consume Jarlsberg cheese during minimum three weeks. Participants obtaining an increased OR ≥ 1 can stop the study. If not, they have to continue until this limit is reached or until maximum five weeks.
- Conditions
- Heathy Women, Pre Menopausal Age, Exlution Criteria: Gastrointestinal Disorder, Liver Disease, Diabetes, Cancer
- Being tested
- Jarlsberg cheese
- Keywords
- Healthy women, Dose respons, Jarlsberg cheese, Osteocalcin
- Medical subject headings
- Liver Diseases, Diabetes Mellitus, Neoplasms, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jarlsberg cheeseDietary supplement
Daily intake of Jarlsberg cheese
| Study group | Role | What they receive |
|---|---|---|
| First design level | Experimental | Three Healthy Voluntary (HV) women were give the same starting daily dose of 100 g Jarlsberg Receives: Dietary Supplement: Jarlsberg cheese |
| Second design level | Experimental | Based on the results from the starting dose 5 + 5 HV get a new daily doses of Jarlsberg cheese Receives: Dietary Supplement: Jarlsberg cheese |
| Third design level | Experimental | Based on the results from the second design level, the daily dose of Jarlsberg cheese for the next 7 HVs was given Receives: Dietary Supplement: Jarlsberg cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteocalcin ratio
Ratio between carboxylated and undercarboxylated osteocalcin
Measured: Five weeks
Secondary outcomes (2)
Lipid profil 1
Triglycerid
Measured: Five weeks
Lipid profil 2
Cholesterol
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Sep 2018
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathy WomenStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- The study will be performed as an open, 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Stig Larsen
- Sponsor type
- University, hospital or other
- Collaborators
- Tine
- Responsible party
- Sponsor-investigator, Prof Stig Larsen, Meddoc
- Investigators
- Helge Lundberg, MD, Principal investigator, Skjetten Legesenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185454
- Sponsor's protocol ID
- HV-Jarlsberg/IA
- Status last verified
- Jan 2023
- First submitted
- 2 Dec 2019
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04185454
- Acronym / sponsor ID
- HV-Jarlsberg/IA
- Conditions
- Heathy Women, Pre Menopausal Age, Exlution Criteria: Gastrointestinal Disorder, Liver Disease, Diabetes, Cancer
- Keywords
- Healthy women, Dose respons, Jarlsberg cheese, Osteocalcin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prof Stig LarsenUniversity, hospital or other
- Collaborators
- Tine
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 4 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.
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.
Detailed description
The recruited HV women fulfil the inclusion without the exclusion criteria for the study will undergo a clinical investigation and blood sampling. The participants will be asked to avoid use of other cheese, but eat as usually. One week later, the first clinical investigation will take place including blood sampling. The HV women verified to fulfil the criteria for participation and signed the informed consent form will be included in the study. The trial treatment consisting of a given gr/day Jarlsberg cheese will start the day after this investigation, denoted as Day 0, and the participants receiving a study identification numbers. They will be instructed not to change eating habit except replace use of other chees with Jarlsberg.
The cheese can be consumed with other food at breakfast and/or lunch. The dose of Jarlsberg cheese per day is fixed per participant and varies from 20 gram per day to 180 gram per day with a mid-dose of 100gr/day. The three patients included at the first design level will all receive this mid-dose of 100gr/day. Clinical investigation and blood sampling after start of the treatment, will be performed after 3, 4, and 5 weeks and the ratio [Carboxylated / Under Carboxylated] Osteocalcin will be calculated. This increased Osteocalcin Ratio (OR) based on the results obtained by the blood sampling at week 3 will be classified in five groups and used for determination of the Jarlsberg cheese dose for the five HV women at design level 2. The classifications of increased OR used are: increased OR < 0.5 classifies as Low; 0.5 ≤ increased OR ≤ 0.9 classifies as Moderate Low; 0.9 < increased OR < 1.1 classifies as Suitable; 1.1≤increased OR≤1.5 classifies as Moderate High; increased OR > 1.5 classifies as High. In case the increased OR is found Low or Moderate Low, the daily dose of Jarlsberg cheese will be reduced for the participants at the second design level. If increased OR classifies as Suitable the same dose as at design level 1 will be recommended applied at the second level and if increased OR classifies as moderate High or High, the Jarlsberg cheese-dose will be increased.
The same procedure based on the results obtained from the five participants at the second design level will be used to determine the daily Jarlsberg-dose for the seven HV women at design level 3. With randomization of the recommended cheese-doses at one design level to be used in the next, the between-patient Response-Surface-Pathway (RSP) design-arm is applied.
The within-patient RSP design-arm is applied and related to the duration of the cheese intake. All the participants will consume Jarlsberg cheese during minimum three weeks. Participants obtaining an increased OR ≥ 1 can stop the study. If not, they have to continue until this limit is reached or until maximum five weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will be performed as an open, 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.
| Arm | Type | Receives |
|---|---|---|
| First design level | Experimental | Dietary Supplement: Jarlsberg cheeseThree Healthy Voluntary (HV) women were give the same starting daily dose of 100 g Jarlsberg |
| Second design level | Experimental | Dietary Supplement: Jarlsberg cheeseBased on the results from the starting dose 5 + 5 HV get a new daily doses of Jarlsberg cheese |
| Third design level | Experimental | Dietary Supplement: Jarlsberg cheeseBased on the results from the second design level, the daily dose of Jarlsberg cheese for the next 7 HVs was given |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy voluntary between 20 years and pre-menopausal age
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 cheeseDaily intake of Jarlsberg cheese | Dietary supplement | First design level, Second design level, Third design level |
Primary outcome
Osteocalcin ratio
Time frame: Five weeks
Ratio between carboxylated and undercarboxylated osteocalcin
2 secondary outcomes
Lipid profil 1
Time frame: Five weeks
Lipid profil 2
Time frame: Five 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 11 Jan 2023.
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 Lundberg, MD principal investigator
Skjetten Legesenter
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 Heathy Women and Pre Menopausal Age, run by Prof Stig Larsen 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 11 Jan 2023. 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?
Osteocalcin ratio (time frame: Five 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 11 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.