Effect of Oral Supplementation With Probiotics (NCT03100162) | Clinical Trial Compass
CompletedNot Applicable
Effect of Oral Supplementation With Probiotics
Poland81 participantsStarted 2016-02-27
Plain-language 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.
Who can participate
Age range45 Years – 70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
…
What they're measuring
1
Number of patients with decreased cardiometabolic risk
Timeframe: At the baseline and after 3 months of treatment