Jarlsberg Cheese Compared to Camembert Cheese

Healthy Women Clinical Trial

Official title:

Effect of Jarlsberg Cheese Compared to Cheese Without Vitamin K2 Regarding Increased Osteocalcin Level in Healthy Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04189796
• Other study ID #: HV-Jarlsberg/III
• Status: Completed
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: November 9, 2020

Study information

• Verified date: June 2022
• Source: Meddoc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 9, 2020
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Women
• Osteocalcin

Intervention

Dietary Supplement:
• Cheese
Daily oral intake of cheese

Locations

Country	Name	City	State
Norway	Skjetten Legesenter	Skjetten	Skedsmo

Sponsors (3)

Lead Sponsor	Collaborator
Prof Stig Larsen	Norwegian University of Life Sciences, Tine

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteocalcin	measured as ng/ml in serum	6 weeks
Primary	Vitamin K	measured as ng/ml in serum	6 weeks
Secondary	Lipids	Total cholesterol, HDL- and LDL-cholesterol measured as mmol/L in serum	6 weeks
Secondary	Vital signs	Systolic- and Diastolic bloodpressure measured in mmHg after 5 minutes in supine position	Every 6 weeks