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Completed

NCT Number: NCT03100162

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.

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Key information

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Education and Obesity Treatment and Metabolic Disorders, Poznan University of Medical Sciences

Poznan, 60-569, Poland

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Collaborators

  • German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE)
  • Poznan University of Life Sciences

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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