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Effect of Oral Supplementation With Probiotics

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ClinicalTrials.gov Identifier: NCT03100162
Recruitment Status : Unknown
Verified March 2017 by Pawel Bogdanski, Poznan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
Department of Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke
Poznan University of Life Sciences
Information provided by (Responsible Party):
Pawel Bogdanski, 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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,

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 27, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of patients with decreased cardiometabolic risk [ Time Frame: 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 :
  1. blood pressure [ Time Frame: At the baseline and following 3 months of treatment ]
  2. Body mass index [ Time Frame: At the baseline and following 3 months of treatment ]
  3. waist circumference [ Time Frame: At the baseline and following 3 months of treatment ]
  4. serum lipids [ Time Frame: At the baseline and following 3 months of treatment ]
  5. Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit [ Time Frame: At the baseline and following 3 months of treatment ]
  6. insulin estimated by immunoassay (DIAsource immunoassays) [ Time Frame: At the baseline and following 3 months of treatment ]
  7. 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 ]
  8. Total body fat content [ Time Frame: 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

  9. Measurement of mineral content in hair [ Time Frame: 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.

  10. Fecal examination (Kalprotektyna, Alfa1 - antytrypsyna ) [ Time Frame: At the baseline and following 3 months of treatment ]
  11. Quality of life [ Time Frame: At the baseline and following 3 months of treatment ]
    "The World Health Organization Quality of Life (WHOQOL) - BREF"



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100162


Contacts
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Contact: Pawel Bogdanski, MD PhD + 48 618549377 pawelbogdanski@wp.pl

Locations
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Poland
Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences Recruiting
Poznan, Poland, 60-569
Contact: Pawel Bogdanski, MD, PhD    +48618549 377    pawelbogdanski@wp.pl   
Sponsors and Collaborators
Poznan University of Medical Sciences
Department of Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke
Poznan University of Life Sciences
Investigators
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Principal Investigator: Pawel Bogdanski, MD PhD Poznan University of Medical Sciences

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Responsible Party: Pawel Bogdanski, Professor, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03100162     History of Changes
Other Study ID Numbers: 871/15
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pawel Bogdanski, Poznan University of Medical Sciences:
probiotics
metabolic syndrome
obesity
microbiome

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases