Jarlsberg Cheese Compared to Camembert Cheese

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:

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.

Study Overview

• Status: Completed
• Conditions: Healthy Women; Osteocalcin
• Intervention / Treatment: Dietary supplement: Cheese

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: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Skedsmo
    • Skjetten, Skedsmo, Norway, 2013
      • Skjetten Legesenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteocalcin	measured as ng/ml in serum	6 weeks
Vitamin K	measured as ng/ml in serum	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipids	Total cholesterol, HDL- and LDL-cholesterol measured as mmol/L in serum	6 weeks
Vital signs	Systolic- and Diastolic bloodpressure measured in mmHg after 5 minutes in supine position	Every 6 weeks

Collaborators and Investigators

• Sponsor: Prof Stig Larsen
• Collaborators: Tine; Norwegian University of Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): September 18, 2020
• Study Completion (Actual): November 9, 2020

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Vitamin K; Cheese intake
• Other Study ID Numbers: HV-Jarlsberg/III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No