Effect of Oral Supplementation With Probiotics

Study Overview
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Brief Summary
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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.

Detailed Description
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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: lipid metabolism- total cholesterol, HDL and LDL cholesterol and triglycerides, blood glucose concentration, blood pressure values, anthropometric parameters, quality of life, the contentl of minerals,

Official Title
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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.

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index (BMI) equal to or greater than 30 kg/m2 age 45 to 70 years stable body weight (< 3 kg self-reported change during the previous three months) written informed consent to participate in the study, > = 1 year after the last menstrual period; abdominal obesity - waist circumference> 80 cm; body fat content measured by bio-impedance ≥ 33%; Exclusion Criteria: secondary obesity or secondary hypertension diabetes type I gastrointestinal disease; dyslipidaemia, type 2 diabetes, hypertension requiring the implementation of pharmacological treatment in the last 3 months prior to observation or follow-up; a history of use of any dietary supplements within the one month prior to the study taking antibiotics within 1 month before starting the study; Clinically relevant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis; simultaneous participation in a study that affects weight change or use of diet / medication / nutritional behaviors affecting body weight changes; consumption of pre- and probiotic-enriched products (for at least 3 weeks prior to the first screening visit) and products with high fiber content or large amounts of fermented foods (> 400g / day); hormone replacement therapy; a history of infection in the month prior to the study nicotine, drug or alcohol abuse vegetarian diet; or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Individuals receive a placebo daily, for 3 months. | Dietary Supplement: Placebo<br> <br> |
| Active Comparator: Probiotic 2g<br>Individuals receive 2 g of probiotic daily, for 3 months. | Dietary Supplement: Probiotic<br> <br> |
| Active Comparator: Probiotic 4g<br>Individuals receive 4 g of probiotic daily, for 3 months. | Dietary Supplement: Probiotic<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with decreased cardiometabolic risk | 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. | At the baseline and after 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | At the baseline and following 3 months of treatment | 
| Body mass index |  | At the baseline and following 3 months of treatment | 
| waist circumference |  | At the baseline and following 3 months of treatment | 
| serum lipids |  | At the baseline and following 3 months of treatment | 
| Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit |  | At the baseline and following 3 months of treatment | 
| insulin estimated by immunoassay (DIAsource immunoassays) |  | At the baseline and following 3 months of treatment | 
| interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit) |  | At the baseline and following 3 months of treatment | 
| Total body fat content | Total body fat content will be measured at baseline and after 3 months of treatment using electrical bioimpedance | At the baseline and following 3 months of treatment | 
| Measurement of mineral content in hair | 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. | At the baseline and following 3 months of treatment | 
| Fecal examination (Kalprotektyna, Alfa1 - antytrypsyna ) |  | At the baseline and following 3 months of treatment | 
| Quality of life | The World Health Organization Quality of Life (WHOQOL) - BREF | At the baseline and following 3 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, metabolic syndrome, obesity, microbiome