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

NCT05434806 | Completed DMC

• 1 other identifier: HV-Jarlsberg/ID
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Jarlsberg cheese

Outcome Measures

Primary Outcomes (2)

• Serum Osteocalcin level

  tOC

  Week 0

• Serum Osteocalcin level

  tOC

  Week 4

Secondary Outcomes (4)

• PINP

  Week 0

• CTX

  Week 0

• PINP

  Week 4

• CTX

  Week 4

Other Outcomes (2)

• cOC

  Week 0

• cOC

  Week 4

Study Arms (2)

Post menomausal women (PMW)

EXPERIMENTAL

40g/day of Jarlsberg cheese will be given three PMW's in the first designlevel. Based on the change in serum osteocalcin level after 4 weeks, the daily Jarlsberg cheese dose for five new PMWs in the second designlevel will be calculated. The results obtained by these five will be used to calculate the dose for seven new PMWs in the third design level.

Dietary Supplement: Jarlsberg cheese

Men passed the age of 65 years

EXPERIMENTAL

40g/day of Jarlsberg cheese will be given three men in the first designlevel. Based on the change in serum osteocalcin level after 4 weeks, the daily Jarlsberg cheese dose for five new men in the second designlevel will be calculated. The results obtained by these five will be used to calculate the dose for seven new men in the third design level.

Dietary Supplement: Jarlsberg cheese

Interventions

Jarlsberg cheese DIETARY_SUPPLEMENT

Daly oral intake

Men passed the age of 65 years; Post menomausal women (PMW)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy post-menopausal women and men passed the age of 65years

You may not qualify if:

• \- 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.
• LDL-cholesterol \> 3 mmol/L or Triglyceride \> 2 mmol/l
• 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)

Skjetten Medical Center

Skjetten, 2013, Norway

Location

Study Officials

• Stig E Larsen, PhD

  Meddoc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Jarlsberg cheese
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: Between-patients Response Surface Pathway (RSP)

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 28, 2022
• Study Start: January 19, 2023
• Primary Completion: May 1, 2023
• Study Completion: June 15, 2023
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All the data from this study will be available in March 2023 and saved in 5 years

Locations

NO (1)