<p class="abstract"><strong>Background:</strong> Cheese is a major source of long-chained vitamin K2 variants. How intake of vitamin K2 rich cheese affects vitamin K and osteocalcin has not been studied. The aim was to establish a maximum efficacy dose (MED) after daily intake of vitamin K2-rich cheese (Jarlsberg^®) based on increase in ratio between carboxylated and undercarboxylated osteocalcin during a five-week diet.</p><p class="abstract"><strong>Methods:</strong> 20 healthy healthy volunteers (HV) were recruited. The daily intake of Jarlsberg^® cheese in the study varied from 20 to 152 g. Clinical investigation was performed initially and after three, four and five weeks with measurement of vital signs, hematological and biochemical variables, carboxylated and undercarboxylated osteocalcin and vitamin K. The ratio OR= carboxylated/undercarboxylated osteocalcin was the main variable.</p><p class="abstract"><strong>Results:</strong> The MED decreased with treatment duration and was estimated to 57 g/day (95% CI: 47-67) after five weeks diet, resulting in a mean OR increase of 30% (95% CI: 23.8-36.8). Both OR and serum osteocalcin followed a quadratic dose response curve. For osteocalcin, a maximal increase of 46% was estimated at 59 g/day for five weeks. The serum content of long-chained vitamin K2 increased significantly with increasing cheese dose. The increase were mainly obtained the first three weeks and kept unchanged the following two weeks. The cheese doses close to the MED caused nearly significant reductions in total cholesterol, LDL-cholesterol, the LDL/HDL ratio and significant reduction in the blood pressures after five weeks diet (p≤0.05).</p><p class="abstract"><strong>Conclusions: </strong>MED of Jarlsberg® cheese was estimated to 57 g/day. Daily intake of Jarlsberg^® cheese increased the osteocalcin level, vitamin K2 and positively affected the lipid patterns and blood pressure.</p>

<p class="abstract"><strong>Background:</strong> Daily maximum effective dose (MED) of Jarlsberg® increased the serum osteocalcin (tOC) level, vitamin K2 and affected the lipid pattern positively. The aim of the study was to estimate and verify a daily maintenance dose.</p><p class="abstract"><strong>Methods:</strong> 12 healthy female volunteers (HV) were included in a de-escalation study after a six week run-in period on the daily MED of 57 g Jarlsberg® cheese. A 3-level within-patient response surface pathway (RSP) design with individual starting values was developed. Another 12 HVs were included in a new study with a six week run-in period on MED followed with six weeks on the estimated maintenance dose. All HVs were premenopausal female between 20 and 52 years of age. The main variable in the studies was the tOC level.</p><p class="abstract"><strong>Results:</strong> tOC, cOC and the vitamin K2 variants increases significantly (p&lt;0.01) during the run-in period on daily MED of Jarlsberg® in both studies. The maintenance daily dose was estimated to 45 g (95% CI: 38-52 g/day) and used in the new study. The tOC level was reduced from 19.8 ng/ml (95% CI: 12.0-27.6) obtained in the run-in period to 18.5 ng/ml (95% CI: 11.7-25.3) during the maintenance part. This represents a reduction of 6.6%. The sum of vitamin K2 variants changed from 0.58 ng/ml on MED of Jarlsberg® to 0.59 ng/ml (95% CI: 0.37-0.82) during the maintenance period.</p><p class="abstract"><strong>Conclusions: </strong>Daily MED of Jarlsberg® cheese increases tOC, cOC and the vitamin K2 level. The maintenance Jarlsberg® dose was estimated to 45 g/day and verified as sufficient.</p>

BackgroundDaily intake of 57 g Jarlsberg cheese has been shown to increase the total serum osteocalcin (tOC). Is this a general cheese effect or specific for Jarlsberg containing vitamin K2 and 1,4-dihydroxy-2naphtoic acid (DHNA)?Methods66 healthy female volunteers (HV) were recruited. By skewed randomisation (3:2), 41 HV were allocated to daily intake of 57 g Jarlsberg (J-group) and 25–50 g Camembert (C-group) in 6 weeks. After 6 weeks the C-group was switched to Jarlsberg. The study duration was 12 weeks with clinical investigations every 6 weeks. The main variables were procollagen type 1 N-terminal propeptide (PINP), tOC, carboxylated osteocalcin (cOC) and the osteocalcin ratio (RO) defined as the ratio between cOC and undercarboxylated osteocalcin (ucOC). Serum cross-linked C-telopeptide type I collagen (CTX), vitamin K2, lipids and clinical chemistry were used as secondary variables.ResultsPINP, tOC, cOC, RO and vitamin K2 increased significantly (p<0.01) after 6 weeks in the J-group. PINP remained unchanged in the C-group. The other variables decreased slightly in the C-group but increased significantly (p≤0.05) after switching to Jarlsberg. No CTX-changes detected in neither of the groups.Serum lipids increased slightly in both groups. Switching to Jarlsberg, total cholesterol and low-density lipoprotein-cholesterol were significantly reduced (p≤0.05). Glycated haemoglobin (HbA1c), Ca++ and Mg++ were significantly reduced in the J-group, but unchanged in the C-group. Switching to Jarlsberg, HbA1c and Ca++ decreased significantly.ConclusionThe effect of daily Jarlsberg intake on increased s-osteocalcin level is not a general cheese effect. Jarlsberg contain vitamin K2 and DHNA which increases PINP, tOC, cOC and RO and decreases Ca++, Mg++ and HbA1c. These effects reflect increased bone anabolism and a possible reduced risk of adverse metabolic outcomes.Trial registration numberNCT04189796.

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