Effect of Oral Supplementation With Probiotics

Poznan University of Medical Sciences (PUMS)

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03100162

871/15

Details and patient eligibility

About

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.

Full 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,

Enrollment: 81 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Individuals receive a placebo daily, for 3 months.

Treatment:

Dietary Supplement: Placebo

Probiotic 2g

Active Comparator group

Description:

Individuals receive 2 g of probiotic daily, for 3 months.

Treatment:

Dietary Supplement: Probiotic

Probiotic 4g

Active Comparator group

Description:

Individuals receive 4 g of probiotic daily, for 3 months.

Treatment:

Dietary Supplement: Probiotic