Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese

NCT04185454 | Completed

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

Brief Summary

Aim: To estimate an oral administered recommended minimum efficacy daily dose (MED) of Jarlsberg cheese in order to obtain the needed increased level of Osteocalcin defined as the ratio \[Carboxylated / Under Carboxylated\] Osteocalcin. Study population: Healthy Voluntary (HV) women between 20 years and pre-menopausal age. Design: Open and randomised two-dimensional single-centre trial with 3-level between-patient Response Surface Pathway (RSP) design in the first dimension and 3-level within-patient RSP design in the secondary dimension.

Conditions

Heathy Women; Pre Menopausal Age; Exlution Criteria: Gastrointestinal Disorder; Liver Disease; Diabetes; Cancer; Kidney Disorder

Keywords

Healthy women; Dose respons; Jarlsberg cheese; Osteocalcin

Outcome Measures

Primary Outcomes (1)

• Osteocalcin ratio

  Ratio between carboxylated and undercarboxylated osteocalcin

  Five weeks

Secondary Outcomes (2)

• Lipid profil 1

  Five weeks

• Lipid profil 2

  Five weeks

Study Arms (3)

First design level

EXPERIMENTAL

Three Healthy Voluntary (HV) women were give the same starting daily dose of 100 g Jarlsberg

Dietary Supplement: Jarlsberg cheese

Second design level

EXPERIMENTAL

Based on the results from the starting dose 5 + 5 HV get a new daily doses of Jarlsberg cheese

Dietary Supplement: Jarlsberg cheese

Third design level

EXPERIMENTAL

Based on the results from the second design level, the daily dose of Jarlsberg cheese for the next 7 HVs was given

Dietary Supplement: Jarlsberg cheese

Interventions

Jarlsberg cheese DIETARY_SUPPLEMENT

Daily intake of Jarlsberg cheese

First design level; Second design level; Third design level

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Healthy voluntary (HV) women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy voluntary between 20 years and pre-menopausal age

You may not qualify if:

• Pregnant women
• 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

• Prof Stig Larsen: lead
• Tine: collaborator

Study Sites (1)

Skjetten Legesenter

Skjetten, Skedsmo, 2013, Norway

Location

MeSH Terms

Conditions

Liver Diseases; Diabetes Mellitus; Neoplasms; Kidney Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Helge Lundberg, MD

  Skjetten Legesenter

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study will be performed as an open, randomised two-dimensional single-centre trial with 3-level between-patient Response Surface Pathway (RSP) design in the first dimension and 3-level within-patient RSP design in the secondary dimension.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: September 1, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

NO (1)