Clinical trial NCT03100162: Effect of Oral Supplementation With Probiotics
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: probiotics
metabolic syndrome
obesity
microbiome
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE)
name: Poznan University of Life Sciences
First posted: 2017-04-04
Enrollment: 81
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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,

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with decreased cardiometabolic risk
timeFrame: At the baseline and after 3 months of treatment
Secondary outcomes:
measure: blood pressure
timeFrame: At the baseline and following 3 months of treatment
measure: Body mass index
timeFrame: At the baseline and following 3 months of treatment
measure: waist circumference
timeFrame: At the baseline and following 3 months of treatment
measure: serum lipids
timeFrame: At the baseline and following 3 months of treatment
measure: Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
timeFrame: At the baseline and following 3 months of treatment
measure: insulin estimated by immunoassay (DIAsource immunoassays)
timeFrame: At the baseline and following 3 months of treatment
measure: interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit)
timeFrame: At the baseline and following 3 months of treatment
measure: Total body fat content
timeFrame: At the baseline and following 3 months of treatment
measure: Measurement of mineral content in hair
timeFrame: At the baseline and following 3 months of treatment
measure: Fecal examination (Kalprotektyna, Alfa1 - antytrypsyna )
timeFrame: At the baseline and following 3 months of treatment
measure: Quality of life
timeFrame: At the baseline and following 3 months of treatment
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences
Study officials:
affiliation: Poznan University of Medical Sciences
name: Pawel Bogdanski, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: