Healthy WomenNCT04189796
Jarlsberg Cheese Compared to Camembert Cheese
A study testing Cheese in people with Healthy Women and Osteocalcin, run by Prof Stig Larsen at 1 site in Norway.
Trial summary
The study objective consists of the following three aims: 1. To compare the effect of daily intake of Jarlsberg cheese and Camembert cheese in change of the Osteocalcin level in healthy women after 6 weeks. 2. 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
- Healthy Women, Osteocalcin
- What is being tested?
- Cheese
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteNorway
- Study dates
- 16 Jan 2020to 9 Nov 2020
- 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
- heathy women from 20 years and within 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: Effect of Jarlsberg Cheese Compared to Cheese Without Vitamin K2 Regarding Increased Osteocalcin Level in Healthy Women
The study objective consists of the following three aims:
- To compare the effect of daily intake of Jarlsberg cheese and Camembert cheese in change of the Osteocalcin level in healthy women after 6 weeks.
- To estimate the long-term increase of the osteocalcin level, change in the lipid pattern and the vital signs caused by optimized daily intake of Jarlsberg cheese.
- To verify the estimated maintaining dose of Jarlsberg cheese related to stabilized osteocalcin Level.
The study population consists of Healthy Voluntary (HV) women between 20 years and pre-menopausal age. The trial will be performed as a randomized Norwegian multicenter study with a semi-cross over design in which the participants randomized to Camembert cheese will be switched to Jarlsberg cheese after 6 weeks.
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 vital 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 HV will randomly be allocated to either daily intake of Jarlsberg cheese or Camembert cheese. The daily intake of cheese will be 57g/day in both study groups.
The participants meet for new clinical investigations every third week with measurement of vital signs and blood sampling. Osteocalcin and vitamin K will be analysed every third week whereas the haematological and biochemical analysis will be performed every six week.
The HVs allocated to Camembert cheese will after 6 weeks be switched to daily intake of Jarlsberg cheese in additional 6 weeks with clinical investigations every third week. The participants performed the 6 weeks of daily intake of Jarlsberg cheese will either be offered participation in the cheese de-escalation study (HV-Jarlsberg/IB) or an extended study of 6 weeks with unchanged Jarlsberg cheese dose. HVs with an increase <10% in the osteocalcin level from screening to 6 weeks of Jarlsberg cheese intake will not be offered included in the de-escalation study. The first 12 HVs finalized 6 weeks with daily intake of Jarlsberg cheese obtaining an increase in the osteocalcin level from baseline ≥10% will be allocated to the de-escalation study HV-Jarlsberg/IB (separate protocol). The HVs included in the extended part of this study will receive an unchanged daily dose of Jarlsberg cheese for additional 6 weeks with clinical investigation every third week. The HVs switched to Jarlsberg cheese may be offered participation in a study part aiming to verify the maintaining dose obtained in HV-Jarlsberg/IB study. The duration of this part will be 6 weeks with clinical investigation every third week.
The main variable in this study will be osteocalcin measured in blood serum. Additionally, carboxylated and under carboxylated Osteocalcin and the ratio OR = [Carboxylated / Under Carboxylated] osteocalcin in serum will be central together 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.Totally 64 HVs completing the study will be recruited from the eight participating General Practitioners sites.
- Conditions
- Healthy Women, Osteocalcin
- Being tested
- Cheese
- Keywords
- Cheese intake, Vitamin K
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CheeseDietary supplement
Daily oral intake of cheese
| Study group | Role | What they receive |
|---|---|---|
| Jarlsberg | Active comparator | Daily intake of Jarlsberg Cheese in at least 6 weeks Receives: Dietary Supplement: Cheese |
| Camembert | Sham comparator | Daily intake of Camembert Cheese in 6 weeks Receives: Dietary Supplement: Cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteocalcin
measured as ng/ml in serum
Measured: 6 weeks
Vitamin K
measured as ng/ml in serum
Measured: 6 weeks
Secondary outcomes (2)
Lipids
Total cholesterol, HDL- and LDL-cholesterol measured as mmol/L in serum
Measured: 6 weeks
Vital signs
Systolic- and Diastolic bloodpressure measured in mmHg after 5 minutes in supine position
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start16 Jan 2020
- Primary completion18 Sep 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy 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
- Parallel groups
- Model description
- The study will be performed as a randomized Norwegian multicenter study with a semi-cross over design in which the participants randomized to Camembert cheese will be switched to Jarlsberg cheese after 6 weeks.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Stig Larsen
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Life Sciences, Tine
- Responsible party
- Sponsor-investigator, Prof Stig Larsen, Meddoc
- Investigators
- Helge E Lundberg, MD, Principal investigator, Skjetten Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189796
- Sponsor's protocol ID
- HV-Jarlsberg/III
- Status last verified
- Jun 2022
- First submitted
- 2 Dec 2019
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lundberg HE, Glaso M, Chhura R, Shukla AA, Austlid T, Sarwar Z, Hovland K, Iqbal S, Fagertun HE, Holo H, Larsen SE. Effect on bone anabolic markers of daily cheese intake with and without vitamin K2: a randomised clinical trial. BMJ Nutr Prev Health. 2022 Aug 2;5(2):182-190. doi: 10.1136/bmjnph-2022-000424. eCollection 2022 Dec.
PubMed 36619332
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Jarlsberg Cheese Compared to Cheese Without Vitamin K2 Regarding Increased Osteocalcin Level in Healthy Women
- ClinicalTrials.gov ID
- NCT04189796
- Acronym / sponsor ID
- HV-Jarlsberg/III
- Conditions
- Healthy Women, Osteocalcin
- Keywords
- Cheese intake, Vitamin K
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Prof Stig LarsenUniversity, hospital or other
- Collaborators
- Norwegian University of Life Sciences, Tine
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 6 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 consists of the following three aims:
- To compare the effect of daily intake of Jarlsberg cheese and Camembert cheese in change of the Osteocalcin level in healthy women after 6 weeks.
- To estimate the long-term increase of the osteocalcin level, change in the lipid pattern and the vital signs caused by optimized daily intake of Jarlsberg cheese.
- To verify the estimated maintaining dose of Jarlsberg cheese related to stabilized osteocalcin Level.
The study population consists of Healthy Voluntary (HV) women between 20 years and pre-menopausal age. The trial will be performed as a randomized Norwegian multicenter study with a semi-cross over design in which the participants randomized to Camembert cheese will be switched to Jarlsberg cheese after 6 weeks.
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 vital 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 HV will randomly be allocated to either daily intake of Jarlsberg cheese or Camembert cheese. The daily intake of cheese will be 57g/day in both study groups.
The participants meet for new clinical investigations every third week with measurement of vital signs and blood sampling. Osteocalcin and vitamin K will be analysed every third week whereas the haematological and biochemical analysis will be performed every six week.
The HVs allocated to Camembert cheese will after 6 weeks be switched to daily intake of Jarlsberg cheese in additional 6 weeks with clinical investigations every third week. The participants performed the 6 weeks of daily intake of Jarlsberg cheese will either be offered participation in the cheese de-escalation study (HV-Jarlsberg/IB) or an extended study of 6 weeks with unchanged Jarlsberg cheese dose. HVs with an increase <10% in the osteocalcin level from screening to 6 weeks of Jarlsberg cheese intake will not be offered included in the de-escalation study. The first 12 HVs finalized 6 weeks with daily intake of Jarlsberg cheese obtaining an increase in the osteocalcin level from baseline ≥10% will be allocated to the de-escalation study HV-Jarlsberg/IB (separate protocol). The HVs included in the extended part of this study will receive an unchanged daily dose of Jarlsberg cheese for additional 6 weeks with clinical investigation every third week. The HVs switched to Jarlsberg cheese may be offered participation in a study part aiming to verify the maintaining dose obtained in HV-Jarlsberg/IB study. The duration of this part will be 6 weeks with clinical investigation every third week.
The main variable in this study will be osteocalcin measured in blood serum. Additionally, carboxylated and under carboxylated Osteocalcin and the ratio OR = [Carboxylated / Under Carboxylated] osteocalcin in serum will be central together 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.Totally 64 HVs completing the study will be recruited from the eight participating General Practitioners sites.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be performed as a randomized Norwegian multicenter study with a semi-cross over design in which the participants randomized to Camembert cheese will be switched to Jarlsberg cheese after 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Jarlsberg | Active comparator | Dietary Supplement: CheeseDaily intake of Jarlsberg Cheese in at least 6 weeks |
| Camembert | Sham comparator | Dietary Supplement: CheeseDaily intake of Camembert Cheese in 6 weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- heathy women from 20 years and within 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 |
|---|---|---|
| CheeseDaily oral intake of cheese | Dietary supplement | Camembert, Jarlsberg |
Primary outcome
Osteocalcin
Time frame: 6 weeks
measured as ng/ml in serum
Vitamin K
Time frame: 6 weeks
measured as ng/ml in serum
2 secondary outcomes
Lipids
Time frame: 6 weeks
Vital signs
Time frame: Every 6 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 5 Jul 2022.
- Derived from this study: PubMed 36619332Lundberg HE, Glaso M, Chhura R, Shukla AA, Austlid T, Sarwar Z, Hovland K, Iqbal S, Fagertun HE, Holo H, Larsen SE. Effect on bone anabolic markers of daily cheese intake with and without vitamin K2: a randomised clinical trial. BMJ Nutr Prev Health. 2022 Aug 2;5(2):182-190. doi: 10.1136/bmjnph-2022-000424. eCollection 2022 Dec.
- Individual participant dataSharing planned: No
Related trials for Healthy Women
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
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 Cheese in people with Healthy Women and Osteocalcin, 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 5 Jul 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. Some participants in this study may receive a placebo. 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 (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04189796, which also lists 1 linked publication.
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 5 Jul 2022.