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Jarlsberg Cheese Compared to Camembert Cheese

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04189796
Recruitment Status : Completed
First Posted : December 6, 2019
Last Update Posted : July 5, 2022
Sponsor:
Collaborators:
Norwegian University of Life Sciences
Tine
Information provided by (Responsible Party):
Prof Stig Larsen, Meddoc

Brief 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. 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.
  3. 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.


Condition or disease Intervention/treatment Phase
Healthy Women Osteocalcin Dietary Supplement: Cheese Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Effect of Jarlsberg Cheese Compared to Cheese Without Vitamin K2 Regarding Increased Osteocalcin Level in Healthy Women
Actual Study Start Date : January 16, 2020
Actual Primary Completion Date : September 18, 2020
Actual Study Completion Date : November 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K

Arm Intervention/treatment
Active Comparator: Jarlsberg
Daily intake of Jarlsberg Cheese in at least 6 weeks
Dietary Supplement: Cheese
Daily oral intake of cheese

Sham Comparator: Camembert
Daily intake of Camembert Cheese in 6 weeks
Dietary Supplement: Cheese
Daily oral intake of cheese




Primary Outcome Measures :
  1. Osteocalcin [ Time Frame: 6 weeks ]
    measured as ng/ml in serum

  2. Vitamin K [ Time Frame: 6 weeks ]
    measured as ng/ml in serum


Secondary Outcome Measures :
  1. Lipids [ Time Frame: 6 weeks ]
    Total cholesterol, HDL- and LDL-cholesterol measured as mmol/L in serum

  2. Vital signs [ Time Frame: Every 6 weeks ]
    Systolic- and Diastolic bloodpressure measured in mmHg after 5 minutes in supine position



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • heathy women from 20 years and within 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189796


Locations
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Norway
Skjetten Legesenter
Skjetten, Skedsmo, Norway, 2013
Sponsors and Collaborators
Prof Stig Larsen
Norwegian University of Life Sciences
Tine
Investigators
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Principal Investigator: Helge E Lundberg, MD Skjetten Medical Center
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Responsible Party: Prof Stig Larsen, Professor, Meddoc
ClinicalTrials.gov Identifier: NCT04189796    
Other Study ID Numbers: HV-Jarlsberg/III
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof Stig Larsen, Meddoc:
Cheese intake
Vitamin K