E66
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Obesity (body mass index (BMI) = 30 kg/m2), waist circumference > 80 cm; percentage of body fat assessed by bioimpedance = 33% and stable body weight in the month prior to the trial (permissible deviation ± 1 kg).
Exclusion criteria
Exclusion criteria: Secondary form of obesity and/or secondary form of hypertension, type 2 diabetes mellitus, history of coronary artery disease, stroke (including transient ischaemic attack), congestive heart failure, clinically significant arrhythmias or conduction disorders, malignancy, history of use of any dietary supplements within 3 months before the study, poorly controlled hypertension (mean systolic blood pressure > 140 mmHg and/or mean diastolic blood pressure > 90 mmHg) during the month prior to the trial and/or necessity to modify antihypertensive treatment in the last 3 months, lipid disorders requiring the implementation of drug treatment in the last 3 months, abnormal liver, kidney, or thyroid gland function, clinically significant acute or chronic inflammatory process within the respiratory, digestive or genitourinary tract or in the oral cavity, pharynx or paranasal sinuses or connective tissue disease or arthritis, history of infection in the month, nicotine, alcohol or drug abuse, pregnancy or childbirth at enrolment or in the 3 months before enrolment, breast-feeding in the 3 months prior to enrolment, any other condition that would make participation not in the best interests of the subject, or could prevent, limit or confound the efficacy of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the following endothelial function parameters: asymmetric dimethylarginine (ADMA), endothelial nitric oxide synthase (eNOS), homocysteine (Hcy), nitrite (NO2), nitrate (NO3), plasminogen activator inhibitor type1 (PAI-1), vascular endothelial growth factor (VEGF). All parameters were measured before and after 3-months of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the following parameters: • anthropometric parameters (body weight, waist and hip circumferences, body mass index (BMI)) • body composition (fat-free mass (FFM), fat mass (FM), visceral adipose tissue (VAT), lean mass index (LMI) and appendicular lean mass index (ALMI)) • densitometric parameters (bone mineral content (BMC) and bone mineral density (BMD)) • physiological parameters and markers related to the function of endothelium (systolic (SBP) and diastolic blood pressure (DBP) and heart rate (HR) during exercise and resting, pulse wave analysis (PWA), pulse wave velocity (PWV)) • physical capacity (work rate ventilatory threshold (WRVT), heart rate ventilatory threshold (HRVT), oxygen uptake peak (VO2 peak), maximal work rate (WRmax), peak heart rate, time to exhaustion (TTE)) • carbohydrate metabolism parameters (fasting glucose, glycated haemoglobin (HbA1C), insulin, insulin-like growth factor (IGF-1), myoglobin, insulin, homeostatic model assessment of insulin resistance (HOMAIR) and quantitative insulin sensitivity check index (QUICKI)) • lipid metabolism parameters (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), oxidized low-density lipoprotein (ox-LDL), apolipoproteins (ApoA, ApoB, ApoE), paraoxonase activity (PON)) • oxidative stress parameters (advanced glycation end products (AGEs)) • antioxidant status parameters (glutathione (GSH), superoxide dismutase (SOD), total antioxidant status (TAS)) • inflammatory markers (high-sensitivity C-reactive protein (hs-CRP), high-sensitivity interleukin-6 (hs-IL-6), high-sensitivity interleukin-8 (hs-IL-8), monocyte chemoattractant protein-1 (MCP-1), matrix metalloproteinase-2 (MMP-2), matrix metalloproteinase-9 (MMP-9), soluble vascular cell adhesion molecule-1 (sVCAM-1), tumour necrosis factor alpha (TNF-a)). All parameters were measured before and after 3-months of intervention. | — |
Countries
Poland
Contacts
Department of Pediatric Gastroenterology and Metabolic Diseases Poznan University of Medical Sciences