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NCT05434806: HV-ID
Daily Dose Estimation of Jarlsberg Cheese in Healthy Norwegian Elderly Male and Female
NA trial testing Jarlsberg cheese in Healthy Aging in 30 participants. Completed in 15 June 2023.
1 May 2023
Quick facts
| Lead sponsor | Meddoc |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 30 |
| Start date | 19 January 2023 |
| Primary completion | 1 May 2023 |
| Estimated completion | 15 June 2023 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Jarlsberg cheese
Conditions studied
- Healthy Aging — all drugs for Healthy Aging →
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.
Verify or expand the search:
- PubMed search for NCT05434806
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Jarlsberg cheese
Trials testing the same drug.
- NCT06358443 — The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia · NA · completed
- NCT06688032 — Efficacy Comparison of Jarlsberg- and Norvegia Cheese on Bone Markers and Bone Mineral Density in Nordic Skiers · NA · completed
- NCT05447936 — Dose Estimation of Jarlsberg Cheese in Young, Active Norwegian Cross-country Skiers (XCS) · NA · completed
- NCT04185454 — Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese · NA · completed
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Currently open trials in the same condition.
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Other Meddoc trials
Trials by the same sponsor.
- NCT06973694 — Validation of Bulbicam Used on Patient Suffering From Diabetes Without Retinopathy · completed
- NCT06358443 — The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia · NA · completed
- NCT05787808 — Profylactic Treatment for Patients in Risk Osteoporosis · NA · recruiting
- NCT06688032 — Efficacy Comparison of Jarlsberg- and Norvegia Cheese on Bone Markers and Bone Mineral Density in Nordic Skiers · NA · completed
- NCT04186585 — Recommended Dose Estimation of BP-C2 · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05434806 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Meddoc
- Last refreshed: 22 May 2024
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing