NCT06688032

Brief Summary

The study objective consists of the following two aims:

  1. 1.Compare the effect of daily intake of Jarlsberg and Norvegia cheese on bonehealth in active Cross Country- and Biathlon skiers of both sexes.
  2. 2.Compare the effect daily intake of Jarlsberg and Norvegia cheese in change of the metabolism , Muscle Strength, Muscle Mass and endurace in active Cross Country- and Biathlon skiers of both sexes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 12, 2024

Last Update Submit

November 14, 2024

Conditions

Keywords

XCSBone markersCheeseMuscle strength

Outcome Measures

Primary Outcomes (1)

  • BMD

    Bone Mineral Density

    From baseline to 24 weeks

Study Arms (2)

Jarlsberg cheese

ACTIVE COMPARATOR

Daily oral intake of 75g and 90g Jarlsberg cheese to females and males, respectively

Other: Jarlsberg cheese

Norvegia cheese

ACTIVE COMPARATOR

Daily oral intake of 75g and 90g Norvegia cheese to females and males, respectively

Other: Norvegia

Interventions

Jarlsberg cheese contains Propionebacterium freudenreichii (PF) producing the K2-vitamer MK-9(4H) and DHNA in addition to the K2-vitamers found in Norvegia cheese

Also known as: Oral daily intake of Jarlsberg cheese
Jarlsberg cheese

Cheese with different content of K2 vitamers

Also known as: Oral daily intake of Norvegia cheese
Norvegia cheese

Eligibility Criteria

Age17 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Active Cross-country and Biathlon skiers from 17 years of age for females and 18 years for males.

You may not qualify if:

  • Eating disorder
  • Pregnancy
  • Serious 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.
  • Known milk product allergy.
  • Suffering from diseases or injuries that disable them to perform VO2 or muscular strength tests.
  • Not able to understand information.
  • Do not want or not able to give written consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport sciences

Oslo, 0863, Norway

Location

Related Publications (1)

  • Lundberg HE, Larsen S, Mathisen TF, Sundgot-Borgen J. Comparison of cheese with and without Propionibacterium freudenreichii subsp. shermanii LMGT 2951 on off-season muscle strength and VO2 max development in Nordic skiers: a randomized clinical trial. J Int Soc Sports Nutr. 2025 Dec;22(1):2566373. doi: 10.1080/15502783.2025.2566373. Epub 2025 Sep 30.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding was not possible due to the look and tast of the two cheeses
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Design and randomization The study was performed as an open randomized stratified parallel group designed trial with two strata. Sex is used as a stratification factor. The two equal sized strata are chosen because of different OED of cheese for women and men, and because the dose-response study previously performed has shown different response in men and women. The participants were equally allocated (1:1) to either Jarlsberg or Norvegia cheese by block randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

April 17, 2023

Primary Completion

October 15, 2023

Study Completion

October 15, 2023

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations