Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences
Poznan, 60-569, Poland
NCT Number: NCT03100162
Effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora and intestinal epithelial permeability, mineral content and lifestyle in obese women with postmenopausal metabolic syndrome: double-blind, randomized clinical trial.
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Notify Me45 year–70 year
Female
Interventional
Not applicable
Poznan, 60-569, Poland
The purpose of the study is to determine whether oral probiotic supplementation affects cardiometabolic risk, intestinal epithelial permeability, metabolic activity and intestinal flora composition, mineral content, and lifestyle in obese women with metabolic syndrome.
Probiotics are a group of non-pathogenic microbes that bring health benefits to the host. Their use enables the variety and proper functioning of intestinal microflora. The use of probiotics increases the amount of bifidobacteria and lactobacilli, what directly affects the reduction of endotoxemia by sealing the intestinal wall, as well as the improvement of fat, carbohydrate and insulin metabolism.
The project is due to evaluate the effect of supplementation with selected probiotics in patients with metabolic syndrome on:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At the baseline and after 3 months of treatment
Cardiometabolic risk will be estimated at baseline and after 3 months of treatment using the SCORE scale. SCORE scale summarize 5 risk factors (sex, age, systolic blood pressure, total cholesterol and smoking). The number of patients with decreased cardiometabolic risk will be measured.
Time frame: At the baseline and following 3 months of treatment
Time frame: At the baseline and following 3 months of treatment
Time frame: At the baseline and following 3 months of treatment
Time frame: At the baseline and following 3 months of treatment
Time frame: At the baseline and following 3 months of treatment
Time frame: At the baseline and following 3 months of treatment
Time frame: At the baseline and following 3 months of treatment
Time frame: At the baseline and following 3 months of treatment
Total body fat content will be measured at baseline and after 3 months of treatment using electrical bioimpedance
Time frame: At the baseline and following 3 months of treatment
The content of iron, magnezium, calcium, selenium, copper and lead in patients' hair at baseline and after 3 months of treatment will be estimated using atomic absorption spectrometry.
Time frame: At the baseline and following 3 months of treatment
Time frame: At the baseline and following 3 months of treatment
"The World Health Organization Quality of Life (WHOQOL) - BREF"
Poznan University of Medical Sciences
Other
Effect of Oral Supplementation With Probiotics on Cardiometabolic Risk Factors, Microflora and Intestinal Epithelial Permeability, Mineral Content and Lifestyle in Obese Women With Postmenopausal Metabolic Syndrome: Double-blind, Randomized Clinical Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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