Influence of Probiotics in Diabetic Cardiopathies With Excessive Weight

Influence of Probiotics in Nutritional, Biochemical Profile and Anxiety of Diabetic Cardiopathies With Excessive Weight: a Randomized Clinical Test

Today in Brazil, 6.9% of the population has Diabetes Mellitus 2 (DM2). In the world, there are about 422 million people with DM2. It is a chronic disease of the endocrine system, accounts for 90 to 95% of cases of DM2 and is characterized by defects in insulin action and secretion. Its main cause is linked to obesity and insulin resistance. Obesity is a chronic, multifactorial disease - environmental, nutritional and genetic factors - characterized by excessive accumulation of body fat, and is reaching epidemic proportions, more than 100 million children and 600 million adults worldwide. The number of obese people in Brazil reaches 17.9% of the population.

Rates of obesity and DM2 have increased in the last decades, both diseases being associated with inflammation and specific alterations in the intestinal microbiota. Thus, studies show that the use of probiotics may be associated with reduced body weight and reduced glucose in the bloodstream. Probiotics are living microorganisms that, when administered in suitable dosages, confer benefits to the health of the host. In addition, studies show the relationship of the intestinal microbiota and the emergence of various diseases and demonstrate that probiotics can control inflammatory processes, metabolic dysfunctions, normalization of stress-induced behaviors, regulation of the hypothalamic-pituitary-adrenal axis and neuropsychiatric disorders. Thus, the importance of investigating the ingestion of probiotics in relation to anthropometry, biochemical profile and anxiety in diabetic and overweight individuals with cardiopathy are justified. It is a randomized, double-blind, controlled clinical trial. The study will last 3 months and will occur with 74 adult individuals (between 20 and 60 years) of the SUS outpatient clinic of the Institute of Cardiology of Porto Alegre - RS, of both sexes, with BMI above 25 m² / kg. and less than 40 m² / kg, divided into 2 groups and 37 individuals per group. These patients were: Group A (intervention: n = 37): patient received 1 sachet per day of probiotics Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum for 90 days and Group B (placebo; n = 37): microcrystalline cellulose, lactose, pregelatinized maize starch. Probiotics will contain a dose of 109 CFU in each strain. The excipients used will be: microcrystalline cellulose.

Study Overview

• Status: Unknown
• Conditions: Anxiety; Diabetes Mellitus Type 2 in Obese; Cardiopathy
• Intervention / Treatment: Dietary supplement: Probiotics; Dietary supplement: Placebo

Detailed Description

Probióticos

• Study Type: Interventional
• Enrollment (Anticipated): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90620000
      • Recruiting
      • Suelen Dallanora
      • Contact: Suelen Dallanora; Phone Number: 55996630616; Email: suu_dallanora@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 20 and 60 years;
• BMI greater than 25 m² / kg and less than 40 m² / kg;
• DM2.

Exclusion Criteria:

• Use of antibiotics or medications for weight loss purposes;
• Use of kefir, yacult;
• Lactose intolerance;
• Inflammatory bowel disease;
• Valvar surgery;
• Use of laxative in the last 3 months;
• Patients participating in other clinical studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; Individuals will receive individual capsules containing the daily dose of lyophilized probiotics (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum) and will be advised to remain at room temperature, drink with water and drink before bed. Probiotics contain a dose of 10 9 CFU per capsule.	Dietary supplement: Probiotics; Individuals will receive individual capsules containing the daily dose of lyophilized probiotics (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum) and will be advised to remain at room temperature, ingest with water and drink before bed.
Placebo Comparator: Placebo; The placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging.	Dietary supplement: Placebo; The placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control of DM2	Blood samples were collected fasting (12h overnight) to determine glycemic and hemoglobin (HbA1c)	3 months
Anxety	To assess anxiety, was applied by a psychologist to the Beck Scale. BAI consists of 21 questions about how the individual has felt in the past week, expressed in common anxiety symptoms (such as sweating and feelings of distress). Each question presents four possible answers, and the one that most closely resembles the individual's mental state must be signaled. The possible answers are: Not; Lightly: did not bother me too much; Moderately: it was unpleasant, but I could bear it; Severely: I hardly supported. BAI can have a maximum score of 63 and the categories are: 0-10: minimum degree of anxiety; 11-19: mild anxiety; 20-30 moderate anxiety; Severe anxiety 31-63.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alteration of serum lipids	Blood samples were collected fasting (fasting of 12h overnight) for glycemia, glycated hemoglobin (HbA1c) in mg / dL, total cholesterol (TC) in mg / dL, high density lipoprotein (HDL-c) in mg / dL, non-HDL in mg / dL and triglycerides in mg / dL. Levels of low-density lipoprotein (LDL in mg / dL) were determined by the Friedewal formula. LDL-c (mg / dL) = TC (mg / dL) - HDL-c (mg / dL) - TG (mg / dL) / 5.	3 months
Weight	Body weights were measured using a portable digital scale (Omron brand) without shoes and minimal clothing.	3 months
Height	The heights were measured with tape measure fixed to the wall.	3 months
BMI	BMI was calculated by dividing body weight (in kilograms) by height (in meters) squared.	3 months

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Investigators: Study Director: Suelen Dallanora, Instituto de Cardiologia

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Heart Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SDallanora

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No