Jarlsberg Cheese Compared to Camembert Cheese

NCT04189796 | Completed DMC

• 1 other identifier: HV-Jarlsberg/III
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective consists of the following three aims:

1. 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. 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. 3.To verify the estimated maintaining dose of Jarlsberg cheese related to stabilized osteocalcin Level.

Conditions

Healthy Women; Osteocalcin

Keywords

Cheese intake; Vitamin K

Outcome Measures

Primary Outcomes (2)

• Osteocalcin

  measured as ng/ml in serum

  6 weeks

• Vitamin K

  measured as ng/ml in serum

  6 weeks

Secondary Outcomes (2)

• Lipids

  6 weeks

• Vital signs

  Every 6 weeks

Study Arms (2)

Jarlsberg

ACTIVE COMPARATOR

Daily intake of Jarlsberg Cheese in at least 6 weeks

Dietary Supplement: Cheese

Camembert

SHAM COMPARATOR

Daily intake of Camembert Cheese in 6 weeks

Dietary Supplement: Cheese

Interventions

Cheese DIETARY_SUPPLEMENT

Daily oral intake of cheese

Camembert; Jarlsberg

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• heathy women from 20 years and within pre-menopausal age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof Stig Larsen: lead
• Norwegian University of Life Sciences: collaborator
• Tine: collaborator

Study Sites (1)

Skjetten Legesenter

Skjetten, Skedsmo, 2013, Norway

Location

Related Publications (1)

• Lundberg HE, Glaso M, Chhura R, Shukla AA, Austlid T, Sarwar Z, Hovland K, Iqbal S, Fagertun HE, Holo H, Larsen SE. Effect on bone anabolic markers of daily cheese intake with and without vitamin K2: a randomised clinical trial. BMJ Nutr Prev Health. 2022 Aug 2;5(2):182-190. doi: 10.1136/bmjnph-2022-000424. eCollection 2022 Dec.

  PMID: 36619332 DERIVED

MeSH Terms

Interventions

Cheese

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Helge E Lundberg, MD

  Skjetten Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 6, 2019
• Study Start: January 16, 2020
• Primary Completion: September 18, 2020
• Study Completion: November 9, 2020
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)