We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 2, 2019
First Posted Date  ICMJE December 6, 2019
Last Update Posted Date July 5, 2022
Actual Study Start Date  ICMJE January 16, 2020
Actual Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • Osteocalcin [ Time Frame: 6 weeks ]
    measured as ng/ml in serum
  • Vitamin K [ Time Frame: 6 weeks ]
    measured as ng/ml in serum
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • Lipids [ Time Frame: 6 weeks ]
    Total cholesterol, HDL- and LDL-cholesterol measured as mmol/L in serum
  • Vital signs [ Time Frame: Every 6 weeks ]
    Systolic- and Diastolic bloodpressure measured in mmHg after 5 minutes in supine position
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Jarlsberg Cheese Compared to Camembert Cheese
Official Title  ICMJE Effect of Jarlsberg Cheese Compared to Cheese Without Vitamin K2 Regarding Increased Osteocalcin Level in Healthy Women
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Healthy Women
  • Osteocalcin
Intervention  ICMJE Dietary Supplement: Cheese
Daily oral intake of cheese
Study Arms  ICMJE
  • Active Comparator: Jarlsberg
    Daily intake of Jarlsberg Cheese in at least 6 weeks
    Intervention: Dietary Supplement: Cheese
  • Sham Comparator: Camembert
    Daily intake of Camembert Cheese in 6 weeks
    Intervention: Dietary Supplement: Cheese
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 9, 2020
Actual Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04189796
Other Study ID Numbers  ICMJE HV-Jarlsberg/III
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Prof Stig Larsen, Meddoc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Prof Stig Larsen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Norwegian University of Life Sciences
  • Tine
Investigators  ICMJE
Principal Investigator: Helge E Lundberg, MD Skjetten Medical Center
PRS Account Meddoc
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP