Effect of Oral Supplementation With Probiotics

NCT03100162 | Completed

• 1 other identifier: 871/15
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

probiotics; metabolic syndrome; obesity; microbiome

Outcome Measures

Primary Outcomes (1)

• 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.

  At the baseline and after 3 months of treatment

Secondary Outcomes (11)

• blood pressure

  At the baseline and following 3 months of treatment

• Body mass index

  At the baseline and following 3 months of treatment

• waist circumference

  At the baseline and following 3 months of treatment

• serum lipids

  At the baseline and following 3 months of treatment

• Total antioxidant status (TAS) evaluated by colorimetric method with Tas Randox kit

  At the baseline and following 3 months of treatment

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Individuals receive a placebo daily, for 3 months.

Dietary Supplement: Placebo

Probiotic 2g

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic

Probiotic 4g

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic 2g; Probiotic 4g

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Poznan, 60-569, Poland

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Pawel Bogdanski, MD PhD

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 4, 2017
• Study Start: February 27, 2016
• Primary Completion: January 4, 2018
• Study Completion: February 2, 2018
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

PL (1)