Dose Estimation of Jarlsberg Cheese in Young, Active Norwegian Cross-country Skiers (XCS)

NCT05447936 | Completed DMC

• 1 other identifier: XCS-Jarlsberg/IC_2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim was to estimate the daily OED of Jarlsberg cheese related to increased total serum Osteocalcin (tOC) level in young, active female and male Cross-country skiers (XCS). The study population consists of active Cross-country Skiers (XCS) of both genders above 18 years of age. The optimal daily intake of Jarlsberg cheese is assumed to have a dose window of \[20 - 100\] gram/day and a starting dose of 47 gram/day for both female and male. The study was performed equally as an open, two-armed within-patient Response Surface Pathway (RSP) trial with three design level and skewed starting dose. The main response variable will be the change in the tOC level after four weeks from baseline of the given design level. Participants, who fulfil the inclusion criteria, do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. All demographic data, social factors, history of disease and vital signs will be recorded at screening. Blood samples was taken at screening and every four weeks. Muscle strength, Peak VO2 and BMD recorded at screening and at the end of the clinical part week12. Ten female and 10 male XCS divided was be included, perform and completed the study.

Conditions

Healthy Nutrition

Keywords

Jarlsberg cheese

Outcome Measures

Primary Outcomes (4)

• tOC

  Total serum Osteocalcin in ng/ml

  Week 0

• tOC

  Total serum Osteocalcin in ng/ml

  Week 4

• tOC

  Total serum Osteocalcin in ng/ml

  Week 8

• tOC

  Total serum Osteocalcin in ng/ml

  Week 12

Secondary Outcomes (12)

• K2

  Week 0

• K2

  Week 4

• K2

  Week 8

• K2

  Week 12

• BMD

  Week 0

Study Arms (2)

Female arm

ACTIVE COMPARATOR

Ten healthy active female XCS past the age of 18 years were included. The duration of the study was 12 weeks divided in three dose-escalation periods of four weeks. In the first 4-week period all the participants was given 47gram Jarlsberg cheese daily. Based on the change in serum Osteocalcin level, the daily intake of Jarlsberg cheese for the next 4-week periode was desided in accordance with the RSP procedure

Dietary Supplement: Jarlsberg cheese

Male arm

ACTIVE COMPARATOR

Ten healthy active male XCS past the age of 18 years were included. The duration of the study was 12 weeks divided in three dose-escalation periods of four weeks. In the first 4-week period all the participants was given 47gram Jarlsberg cheese daily. Based on the change in serum Osteocalcin level, the daily intake of Jarlsberg cheese for the next 4-week periode was desided in accordance with the RSP procedure

Dietary Supplement: Jarlsberg cheese

Interventions

Jarlsberg cheese DIETARY_SUPPLEMENT

Jarlsberg cheese is a regular cheese for free sale in grocery stores. The allotted amount of cheese was taken orally each day

Also known as: Vitamin D

Female arm; Male arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy active XCS of both genders past the age of 18 years

You may not qualify if:

• Eating disorder
• Pregnancy
• 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

• Meddoc: lead
• Tine: collaborator

Study Sites (1)

Meddoc

Skjetten, Akershus, 2013, Norway

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Stig E Larsen, PhD

  Meddoc

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The participants were divided into men and women. Within each of these two arms, a three-step dose escalation was performed according to a Respons Surface Pathway procedure.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: May 11, 2021
• Primary Completion: August 12, 2021
• Study Completion: October 8, 2021
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)