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NCT05434806: HV-ID

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

Completed NA Last updated 22 May 2024
What this trial tests

NA trial testing Jarlsberg cheese in Healthy Aging in 30 participants. Completed in 15 June 2023.

Timeline
19 January 2023
Primary endpoint
1 May 2023
15 June 2023

Quick facts

Lead sponsorMeddoc
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment30
Start date19 January 2023
Primary completion1 May 2023
Estimated completion15 June 2023
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Meddoc — full company profile →

Who can join

Adults 65 to 80, any sex, with Healthy Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Jarlsberg cheese

Trials testing the same drug.

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Other Meddoc trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing