Back to resultsEffect of Oral Supplementation With Probiotics
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring probiotics, metabolic syndrome, obesity, microbiome
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
Sites / Locations
- Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Probiotic 2g
Probiotic 4g
Arm Description
Individuals receive a placebo daily, for 3 months.
Individuals receive 2 g of probiotic daily, for 3 months.
Individuals receive 4 g of probiotic daily, for 3 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
blood pressure
Body mass index
waist circumference
serum lipids
Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
insulin estimated by immunoassay (DIAsource immunoassays)
interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit)
Total body fat content
Total body fat content will be measured at baseline and after 3 months of treatment using electrical bioimpedance
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.
Fecal examination (Kalprotektyna, Alfa1 - antytrypsyna )
Quality of life
"The World Health Organization Quality of Life (WHOQOL) - BREF"
Full Information
NCT ID
NCT03100162
First Posted
March 22, 2017
Last Updated
May 4, 2020
Sponsor
Poznan University of Medical Sciences
Collaborators
German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE), Poznan University of Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03100162
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2016 (Actual)
Primary Completion Date
January 4, 2018 (Actual)
Study Completion Date
February 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences
Collaborators
German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE), Poznan University of Life Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
probiotics, metabolic syndrome, obesity, microbiome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Individuals receive a placebo daily, for 3 months.
Arm Title
Probiotic 2g
Arm Type
Active Comparator
Arm Description
Individuals receive 2 g of probiotic daily, for 3 months.
Arm Title
Probiotic 4g
Arm Type
Active Comparator
Arm Description
Individuals receive 4 g of probiotic daily, for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of patients with decreased cardiometabolic risk
Description
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.
Time Frame
At the baseline and after 3 months of treatment
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
At the baseline and following 3 months of treatment
Title
Body mass index
Time Frame
At the baseline and following 3 months of treatment
Title
waist circumference
Time Frame
At the baseline and following 3 months of treatment
Title
serum lipids
Time Frame
At the baseline and following 3 months of treatment
Title
Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit
Time Frame
At the baseline and following 3 months of treatment
Title
insulin estimated by immunoassay (DIAsource immunoassays)
Time Frame
At the baseline and following 3 months of treatment
Title
interleukin-6 measured by an enzyme-linked immunosorbent assay (R&D Quantikine® Human Il-6 kit)
Time Frame
At the baseline and following 3 months of treatment
Title
Total body fat content
Description
Total body fat content will be measured at baseline and after 3 months of treatment using electrical bioimpedance
Time Frame
At the baseline and following 3 months of treatment
Title
Measurement of mineral content in hair
Description
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.
Time Frame
At the baseline and following 3 months of treatment
Title
Fecal examination (Kalprotektyna, Alfa1 - antytrypsyna )
Time Frame
At the baseline and following 3 months of treatment
Title
Quality of life
Description
"The World Health Organization Quality of Life (WHOQOL) - BREF"
Time Frame
At the baseline and following 3 months of treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pawel Bogdanski, MD PhD
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Oral Supplementation With Probiotics
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