Effect of Oral Supplementation With Probiotics

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT03100162
• Lead Sponsor: Poznan University of Medical Sciences

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,

Study Timeline

• Study Start: 2016-02-27
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Primary Completion: 2018-01-04
• Study Completion: 2018-02-02
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-04
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Individuals receive a placebo daily, for 3 months.
Probiotic 2g	Probiotic	Individuals receive 2 g of probiotic daily, for 3 months.
Probiotic 4g	Probiotic	Individuals receive 4 g of probiotic daily, for 3 months.

Primary Outcome Measures

Name	Time	Method
Number of patients with decreased cardiometabolic risk	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.

Secondary Outcome Measures

Name	Time	Method
serum lipids	At the baseline and following 3 months of treatment
blood pressure	At the baseline and following 3 months of treatment
Body mass index	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
Quality of life	At the baseline and following 3 months of treatment	"The World Health Organization Quality of Life (WHOQOL) - BREF"
waist circumference	At the baseline and following 3 months of treatment
insulin estimated by immunoassay (DIAsource immunoassays)	At the baseline and following 3 months of treatment
Measurement of mineral content in hair	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.
Fecal examination (Kalprotektyna, Alfa1 - antytrypsyna )	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
Total body fat content	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

Trial Locations

Locations (1)

Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences; 🇵🇱 Poznan, Poland