Effect of consumption of beneficial bacteria associated with diet on body fat, intestinal health and aspects related to the immune system of obese people

Not Applicable

• Conditions: Obesity; C18.654.726.500

• Registration Number: RBR-8cy8xb
• Lead Sponsor: Camila Guazzelli Marques

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Male volunteers; sedentary; age between 20 to 40 years; body mass index (BMI) between 30.0 and 34.99kg / m2, which is obtained by dividing body weight, measured in kilograms, by the square height, measured in meters (kg / m2)

Exclusion Criteria

diabetics; vegetarians and vegans; accompanying with a nutritionist; performing any diet or food restriction; gastrointestinal surgery; using antibiotics in the last six months and anti-inflammatory drugs in the last fifteen days and the evaluation weeks; use of weight loss medications and/or antidepressants; use of drugs from the serotonin receptor family; regular consumption of probiotic/fermented products (kefir and kombucha); use of nutritional supplements (probiotics, prebiotics, symbiotics, multivitamins, omega-3, Whey Protein, and creatine); smokers; consumption of alcoholic beverages (> 30.0 grams of alcohol per week); regular physical exercise at least twice a week

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: to evaluate the reduction of fat tissue in obese individuals, determined by the assessment of body composition verified through the plestimography method at the beginning (baseline), middle (4th and 8th week) and end of the study (12th week)

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes of the study consist of assessing changes in the composition and diversity of the intestinal microbiota, attenuating the metabolic endotoxemia process and, therefore, the systemic inflammatory processes, which will evaluate using laboratory tests and stool analysis methods performed at the beginning and end of the study