E66
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: BMI = 25.0 kg/m², menopause: at least 12 months prior to study enrolment
Exclusion criteria
Exclusion criteria: Menopause before the age of 40 years, previously diagnosed osteoporosis or other bone diseases, taking medications that affect bone metabolism, taking hormone replacement therapy, taking calcium or vitamin K supplements in the last 3 months, diagnosed acute or chronic autoimmune diseases, inflammatory diseases, infectious diseases, viral, bacterial or parasitic infections, malignant neoplastic disease treated with chemo- or radiotherapy within the last 5 years, acute and chronic kidney and liver diseases, underactive or overactive parathyroid glands.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density (BMD), bone mineral content (BMC), osteocalcin, bone-specific alkaline phosphatase (BSAP), cross-linked C-terminal telopeptide of type I collagen (CTX-I) will be assessed before and after the 12-month intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting glucose and insulin, homeostasis model assessment of insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), asymmetric dimethylarginine (ADMA), soluble vascular cell adhesion molecule-1 (sVCAM-1), high-sensitivity C-reactive protein (hs-CRP), AGEs, 25-hydroxyvitamin D (25(OH)D), systolic (SBP) and diastolic blood pressure (DBP), body weight, waist and hip circumference, body mass index (BMI), percentage of fat (%FM), free-fat mass (%FFM) and visceral adipose tissue (VAT) will be assessed before and after the 12-month intervention period. | — |
Countries
Poland
Contacts
Department of Pediatric Gastroenterology and Metabolic DiseasesPoznan University of Medical Sciences