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

NCT05447936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-07-07

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Jarlsberg cheese

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

Sponsors & Collaborators

  • Tine

    collaborator INDUSTRY

  • Meddoc

    lead OTHER

Principal Investigators

  • Stig E Larsen, PhD · Meddoc

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2021-08-12
Completion
2021-10-08

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447936 on ClinicalTrials.gov