Jarlsberg Cheese Compared to Camembert Cheese
Condition: Healthy Women; Osteocalcin
Study type: Interventional

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.
    

Intervention name(s): Cheese
Intervention type(s): Dietary Supplement
Intervention description(s): Daily oral intake of cheese
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
Keywords: Cheese intake; Vitamin K