Table 2.

Primary and secondary outcome measures in the NuEva study.

Primary outcome measure (plasma, five times plus follow-up)

▪ Low density lipoprotein (LDL)/high density lipoprotein (HDL) ratio

Secondary measures (plasma/serum, five times plus follow-up)

▪ Total cholesterol, triacylglycerides, lipoprotein (a), apolipoprotein AI, B ▪ Anthropometric and physiological data (height, weight, waist circumference, blood pressure, bioelectric impedance measurement) ▪ Vitamins (A, D, E, B1, B2, B6, folic acid, B12) and vitamin B12 status marker (holotranscobalamin, methylmalonic acid, homocysteine) ▪ Minerals [calcium, sodium, potassium, iron, and iron status markers (ferritin, transferrin)] ▪ Trace elements (copper, zinc, manganese, total selenium and selenoprotein P, glutathione peroxidase (GPx) activity) ▪ Fatty acid distribution in plasma lipids and erythrocyte lipids (> 90 fatty acids) ▪ Additional cardiovascular risk factors (high sensitive c-reactive protein, uric acid) ▪ Diabetes risk factors [fasting glucose, fasting insulin, hemoglobin A1c (HbA1c)] ▪ Clotting markers (alpha prothrombin time, fibrinogen, international normalized ratio, quick value) and blood count ▪ Cholesterol synthesis markers/cholesterol resorption markers ▪ Bone turnover (bone-specific alkaline phosphatase, osteocalcin, β-crosslaps (CTX), N-terminal propeptide of type I procollagen (PINP), parathyroid hormone) ▪ Thyroid function [thyroid-stimulating hormone, free thyroxine (T4), free triiodothyronine (T3)] ▪ Optional: targeted metabolic profiling (AbsoluteIDQ p180 Kit from Biocrates), inclusive unbound free fatty acid profiles in plasma

Secondary measures (24 h urine, at the beginning and after 12 months)

▪ Albumin, creatinine ▪ Sodium, magnesium, zinc, selenium, iodine ▪ Heavy metals (arsenic, lead, cadmium, mercury)

Secondary measures (feces collection, at the beginning and after 12 months)

▪ Distribution of the gut microbiome