The effect of low advanced glycation end product (AGEs) diet on bone health and cardio-metabolic parameters in obese postmenopausal women: a randomized controlled trial

Not Applicable

Recruiting

• Conditions: E66; Obesity

• Registration Number: DRKS00034643
• Lead Sponsor: Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

BMI = 30.0 kg/m², menopause: at least 12 months prior to study enrolment

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.