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Daily Dose Estimation of Jarlsberg Cheese in Healthy Norwegian Elderly Male and Female

NCT05434806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-22

No results posted yet for this study

Summary

Aim: To estimate OED of Jarlsberg cheese and the stabilized level of serum Osteocalcin in healthy elderly men and women.

Study population consists of healthy men at least 65 years old and healthy post-menopausal women.

Trial treatment: Daily intake of Jarlsberg cheese within a window of \[20 - 100\] gram/day and a starting dose of 40 gram/day Design: The study will be performed as an open, two-armed between-patient randomized Response Surface Pathway (RSP) study with three design level and skewed starting dose.

Study procedure: HVs who fulfils 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 one week later. All demographic data, social factors and history of disease will be recorded. The design consists of three design levels and measurement taken at screening, after four weeks daily intake of the decided dose of Jarlsberg cheese. At screening, after four weeks of daily intake of Jarlsberg cheese, a physical examination ,CTCAE and concomitant medication will be performed. Additionally, blood sampling will be taken at screening and after four weeks for measurements of Osteocalcin, PINP, CTX, BALP, vitamin K and common laboratory variables.

Sample size: Fifteen female and 15 male HVs divided on 3 design levels.

Conditions

  • Healthy Aging

Interventions

DIETARY_SUPPLEMENT

Jarlsberg cheese

Daly oral intake

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
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-19
Primary Completion
2023-05-01
Completion
2023-06-15

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 NCT05434806 on ClinicalTrials.gov