Obesity
Conditions
Interventions
This is a non-randomized single-arm clinical trial pre- and post-intervention with adult and elderly overweight and obese patients assisted by the Nutrition Outpatient Clinic of the University Hospita
Sponsors
Fundação Universidade Federal de Sergipe
Fundação Universidade Federal de Sergipe
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Adult patients up to 59 years of age, of both sexes, will be included; obese with a Body Mass Index (BMI) greater than or equal to 30 kilograms per square meter (kg/m²); followed by the Nutrition Clinic of the University Hospital of Aracaju/Sergipe
Exclusion criteria
Exclusion criteria: Patients who are pregnant; using corticosteroids, antimicrobials and/or prebiotic, probiotic or synbiotic supplements during the study; and who have a diagnosis of inflammatory bowel disease, celiac disease, lactose intolerance, or intestinal resections will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected: To assess blood glucose levels using biochemical tests. Fasting blood glucose, glycated hemoglobin, and insulin will be analyzed.;Expected Outcome 1: To evaluate the glycemic level of overweight and obese patients after consuming a supplement containing Lactobacillus casei strains, verified by the biochemical sample collection method using the Immunoturbidimetric Inhibition method for Glycated Hemoglobin (HbA1c), Enzymatic Method for Fasting Glucose, and Electrochemiluminescence for Insulin. A decrease in Insulin, Fasting Glucose, and Glycated Hemoglobin levels is expected. Outcome Finding 1: Evaluate the glycemic and insulin profile, verified by the biochemical sample collection method. It was observed that the mean insulin level decreased from 22.69 ± 24.14 µU/mL to 20.75 ± 26.72 µU/mL. This reduction in insulin was statistically significant (p = 0.028). Fasting glucose (p = 0.66) and glycated hemoglobin (p = 0.79) remained stable and did not show a significant difference. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: To evaluate participants' body composition parameters before and after the intervention, verified by the anthropometric data measurement method using a digital scale, wall stadiometer, and inelastic measuring tape. It is expected that a decrease in the parameters of Weight, Body Mass Index (BMI), Abdominal Circumference (AC), Wrist Circumference (WC), Neck Circumference (NC), and Hip Circumference (HC) will be observed. Outcome 1: Evaluate body composition parameters, verified by the anthropometric data measurement method using a digital scale for weight, a wall stadiometer for height, and an inelastic measuring tape for measuring body circumferences. It was observed that weight (p = 0.96), Body Mass Index (BMI) (p = 1.00), and circumferences (waist circumference, hip circumference, neck circumference, and wrist circumference) did not show significant differences after the intervention (p between 0.24 and 1.00). Expected Outcome 2: Verify the evolution of serum biochemical markers in the sample individuals before and after the intervention, verified by the biochemical data collection method. The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) and HOMA-BETA indices will be analyzed. A reduction in the HOMA-IR index is expected. Outcome 2: Verify the evolution of the HOMA-IR Index. Verified by the calculation method based on fasting glucose and insulin data. It was observed that the HOMA-IR index did not show a significant difference (p = 0.18) after the intervention. | — |
Countries
Brazil
Contacts
Public ContactAlex Júnior
Fundação Universidade Federal de Sergipe
Outcome results
None listed