Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2016-02-27
2018-02-02
Brief Summary
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Detailed Description
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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,
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Individuals receive a placebo daily, for 3 months.
Placebo
Probiotic 2g
Individuals receive 2 g of probiotic daily, for 3 months.
Probiotic
Probiotic 4g
Individuals receive 4 g of probiotic daily, for 3 months.
Probiotic
Interventions
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Probiotic
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
70 Years
FEMALE
No
Sponsors
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German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE)
UNKNOWN
Poznan University of Life Sciences
OTHER
Poznan University of Medical Sciences
OTHER
Responsible Party
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Pawel Bogdanski
Professor
Principal Investigators
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Pawel Bogdanski, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Poznan University of Medical Sciences
Locations
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Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences
Poznan, , Poland
Countries
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Other Identifiers
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871/15
Identifier Type: -
Identifier Source: org_study_id
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