Effect of Oral Supplementation With Probiotics

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.

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 Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland, 60-569
    • Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Individuals receive a placebo daily, for 3 months.	Dietary supplement: Placebo
Active Comparator: Probiotic 2g; Individuals receive 2 g of probiotic daily, for 3 months.	Dietary supplement: Probiotic
Active Comparator: Probiotic 4g; Individuals receive 4 g of probiotic daily, for 3 months.	Dietary supplement: Probiotic

What is the study measuring?

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
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
Body mass index		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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Collaborators: Poznan University of Life Sciences; German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE)
• Investigators: Principal Investigator: Pawel Bogdanski, MD PhD, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2016
• Primary Completion (Actual): January 4, 2018
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: obesity; probiotics; metabolic syndrome; microbiome
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome
• Other Study ID Numbers: 871/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No